FDA.reportPublic FDA data

PRESTIGE AMERITECH

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30050224833005022483PRESTIGE AMERITECH1Y2026-01-017201 Iron Horse Blvd. North Richland Hills TX US 76180

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00811220030353PremierPro Lancet - Color: PinkInstructions for use1. Twist off the protective cap and pull it straight out.2. Press the safety lancet body firmly against the puncture site to activate the device.3. Gently apply intermittent pressure near the puncture site to obtain the required blood volume.Warnings1. Do not use if protective cap has been previously removed from lancet.2. Clean the injection site prior to use following established procedure.3. Discard used lancet into a sharps container in accordance with facility guidelines, national and state regulations.1-855-531-7699info@s2s-global.com
00811220030759PremierPro Surgeons Glove - Neoprene, PF, Micro, Size 6.5, PairColor Neutral855-531-7699info@s2s-global.com
00818566016454PremierPro - Earloop Procedure Mask, Anti-Fog Foam & Visor, ASTM 3, Sea Blue1-855-531-7699udi@s2s-global.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
647161030905516K984558DERMA PRENE POWDER-FREE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE)KGO1999-02-26
647161869329883K231741ProGear® Surgical Mask with Oxafence®, Model AV82030OUK2024-09-05
647161088774181K222225Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue)LZA2022-11-11
647161496061017K220118Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free Examination GlovesLZA2022-05-12
647161367642252K182600Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue)LZA2018-11-30
647161314116734K171873Powder Free Nitrile Patient Examination Glove, Blue Colored, Non Sterile, Tested for Use with Chemotherapy DrugsLZA2017-11-15
647161703581789K171162Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap ShieldFXX2017-08-15
647161371003429K170136Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy DrugsLZA2017-08-25
647161163846447K160100Prestige Ameritech Pediatric/Child’s Face maskOXZ2016-10-07
647161150472897K152561Communicator Surgical Facemask with Clear WindowFXX2016-06-03
647161060487985K151694Gammex PI Hybrid Surgical GlovesKGO2016-03-09
647161339788596K103714ENCORE ACCLAIM STERILE POWDER-FREE LATEX SURGICAL GLOVES, TESTED FOR USE WITH CHEMOTHERAKGO2011-07-07
647161733396123K102096POWDER FREE NITRILE EXAMINATION GLOVES, BLUELZA2010-10-04
647161908335116K102092PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIESMSH2010-10-06
647161701112509K071746DERMA PRENE PI OR ISOTOUCH GREEN STERILE POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVESKGO2007-12-13
647161950361439K061716PRESTIGE AMERITECH FACE MASKFXX2006-08-14
647161040124979K051793ENCORE STERILE POWDER-FREE LATEX SURGICAL GLOVE WITH PROPRIETARY COATING (CONTAINING GLYCERINE)KGO2005-08-17
647161430295377K000295ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)KGO2000-02-16
647161044290619
647161077065453
647161267928164
647161318730128
647161557468862
647161632602527
647161760844949

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LZA62022-11-11
KGO62016-03-09
FXX32017-08-15
OUK12024-09-05
OXZ12016-10-07
MSH12010-10-06

PMN#

GUDID#

PremierPro Lancet - Color: PinkInstructions for use1. Twist off the protective cap and pull it straight out.2. Press the safety lancet body firmly against the puncture site to activate the device.3. Gently apply intermittent pressure near the puncture site to obtain the required blood volume.Warnings1. Do not use if protective cap has been previously removed from lancet.2. Clean the injection site prior to use following established procedure.3. Discard used lancet into a sharps container in accordance with facility guidelines, national and state regulations.

PRESTIGE AMERITECH, LTD.

2018-08-03

PremierPro Air Transfer Mats - "PremierPro™ Air Transfer Mats are indicated for patients who are unable to transfer or turn by their own effort, both assisted and unassisted. Whose size and weight present possible risks to caregivers involved in the transfer of the patient. Use 2 or more caregivers during patient transfers. Do not use transfer mat until user manual is reviewed. Do not leave patient unattended on inflated transfer mat. Do not attempt to move patient on uninflated transfer mat. The maximum safe working load for all is l000lbs. AIR SUPPLY units may be compatible if they provide 3 psi pressure and 80 cfm capacity. The hose used may be a standard 1.75"" diameter hose that may be secured with a snap fastener or hook & loop fastener. Always refer the air supply unit's operating instructions, observing all precautions and warnings. All safety guidelines within the air supply unit's operating instructions should be followed. May be used in situations that require transferring patients undergoing Magnetic Resonance Imaging. PremierPro Air Transfer Mats have been evaluated for use with MRI and have been determined to be safe for use. This conclusion is based on: Materials of construction for top and bottom fabrics include Nylon, PVC and Mesh. Air supply fasteners are not in the radio frequency field or the field of imaging and will not cause artifacts. Evaluation of these factors indicates PremierPro Air Transfer Mats are safe when used with patients undergoing MRI. Reusable models may be wiped down with disinfectant or laundered between patients. When laundering, a water and bleach mixture of 100:1 may be used. Wash the mat using hot water (s160° F/ 65° C) with a cold-water rinse. When drying, the dryer temperature should be s140° F/60° C. Drying time should be set at 60 mts. or less. The ""Wrinkle Free"" setting on the dryer should be set to ""Off"". The PremierPro Reusable Air Transfer Mat may also be air dried. The Air Transfer Mats may show signs of wear after repeated drying."

PRESTIGE AMERITECH, LTD.

2018-04-10

PremierPro Air Transfer Mats - "PremierPro™ Air Transfer Mats are indicated for patients who are unable to transfer or turn by their own effort, both assisted and unassisted. Whose size and weight present possible risks to caregivers involved in the transfer of the patient. Use 2 or more caregivers during patient transfers. Do not use transfer mat until user manual is reviewed. Do not leave patient unattended on inflated transfer mat. Do not attempt to move patient on uninflated transfer mat. The maximum safe working load for all is l000lbs. AIR SUPPLY units may be compatible if they provide 3 psi pressure and 80 cfm capacity. The hose used may be a standard 1.75"" diameter hose that may be secured with a snap fastener or hook & loop fastener. Always refer the air supply unit's operating instructions, observing all precautions and warnings. All safety guidelines within the air supply unit's operating instructions should be followed. May be used in situations that require transferring patients undergoing Magnetic Resonance Imaging. PremierPro Air Transfer Mats have been evaluated for use with MRI and have been determined to be safe for use. This conclusion is based on: Materials of construction for top and bottom fabrics include Nylon, PVC and Mesh. Air supply fasteners are not in the radio frequency field or the field of imaging and will not cause artifacts. Evaluation of these factors indicates PremierPro Air Transfer Mats are safe when used with patients undergoing MRI. Reusable models may be wiped down with disinfectant or laundered between patients. When laundering, a water and bleach mixture of 100:1 may be used. Wash the mat using hot water (s160° F/ 65° C) with a cold-water rinse. When drying, the dryer temperature should be s140° F/60° C. Drying time should be set at 60 mts. or less. The ""Wrinkle Free"" setting on the dryer should be set to ""Off"". The PremierPro Reusable Air Transfer Mat may also be air dried. The Air Transfer Mats may show signs of wear after repeated drying."

PRESTIGE AMERITECH, LTD.

2018-04-10

PremierPro Air Transfer Mats - "PremierPro™ Air Transfer Mats are indicated for patients who are unable to transfer or turn by their own effort, both assisted and unassisted. Whose size and weight present possible risks to caregivers involved in the transfer of the patient. Use 2 or more caregivers during patient transfers. Do not use transfer mat until user manual is reviewed. Do not leave patient unattended on inflated transfer mat. Do not attempt to move patient on uninflated transfer mat. The maximum safe working load for all is l000lbs. AIR SUPPLY units may be compatible if they provide 3 psi pressure and 80 cfm capacity. The hose used may be a standard 1.75"" diameter hose that may be secured with a snap fastener or hook & loop fastener. Always refer the air supply unit's operating instructions, observing all precautions and warnings. All safety guidelines within the air supply unit's operating instructions should be followed. May be used in situations that require transferring patients undergoing Magnetic Resonance Imaging. PremierPro Air Transfer Mats have been evaluated for use with MRI and have been determined to be safe for use. This conclusion is based on: Materials of construction for top and bottom fabrics include Nylon, PVC and Mesh. Air supply fasteners are not in the radio frequency field or the field of imaging and will not cause artifacts. Evaluation of these factors indicates PremierPro Air Transfer Mats are safe when used with patients undergoing MRI. Reusable models may be wiped down with disinfectant or laundered between patients. When laundering, a water and bleach mixture of 100:1 may be used. Wash the mat using hot water (s160° F/ 65° C) with a cold-water rinse. When drying, the dryer temperature should be s140° F/60° C. Drying time should be set at 60 minutes or less. The ""Wrinkle Free"" setting on the dryer should be set to ""Off"". The PremierPro Reusable Air Transfer Mat may also be air dried. The Air Transfer Mats may show signs of wear after repeated drying."

PRESTIGE AMERITECH, LTD.

2018-04-10

PremierPro Air Transfer Mats - "PremierPro™ Air Transfer Mats are indicated for patients who are unable to transfer or turn by their own effort, both assisted and unassisted. Whose size and weight present possible risks to caregivers involved in the transfer of the patient. Use 2 or more caregivers during patient transfers. Do not use transfer mat until user manual is reviewed. Do not leave patient unattended on inflated transfer mat. Do not attempt to move patient on uninflated transfer mat. The maximum safe working load for all is l000lbs. AIR SUPPLY units may be compatible if they provide 3 psi pressure and 80 cfm capacity. The hose used may be a standard 1.75"" diameter hose that may be secured with a snap fastener or hook & loop fastener. Always refer the air supply unit's operating instructions, observing all precautions and warnings. All safety guidelines within the air supply unit's operating instructions should be followed. May be used in situations that require transferring patients undergoing Magnetic Resonance Imaging. PremierPro Air Transfer Mats have been evaluated for use with MRI and have been determined to be safe for use. This conclusion is based on: Materials of construction for top and bottom fabrics include Nylon, PVC and Mesh. Air supply fasteners are not in the radio frequency field or the field of imaging and will not cause artifacts. Evaluation of these factors indicates PremierPro Air Transfer Mats are safe when used with patients undergoing MRI. Reusable models may be wiped down with disinfectant or laundered between patients. When laundering, a water and bleach mixture of 100:1 may be used. Wash the mat using hot water (s160° F/ 65° C) with a cold-water rinse. When drying, the dryer temperature should be s140° F/60° C. Drying time should be set at 60 mts. or less. The ""Wrinkle Free"" setting on the dryer should be set to ""Off"". The PremierPro Reusable Air Transfer Mat may also be air dried. The Air Transfer Mats may show signs of wear after repeated drying."

PRESTIGE AMERITECH, LTD.

2018-04-10

PremierPro Air Transfer Mats - "ReusableINTENDED USE/ CONTRAINDICATIONSPrernierPro'"" Air Transfer Mats are indicated for patients• Who are unable to transfer or turn by their own effort. both assisted and unassisted• Whose size and weight present possible risks to caregivers involved in the transfer of the patientPRECAUTIONS & WARNINGS• Use two or more caregivers during patient transfers• Do not use transfer mat until user manual is reviewed.• Do not leave patient unattended on inflated transfer mat• Do not attempt to move patient on uninflated transfer mat.• The maximum safe working load for all PremierPro""' Air Transfer Mats is 1,000Ibs (450kg)AIR SUPPLYAir supply units may be compatible with PremierPro' "" Air Transfer Mats if they provide 3 psi pressure and 80 cfm capacity. The hose used may be a standard 1.75"" diameter hose that may be secured with a snap fastener or hook & loop fastener. Always refer the air supply unit’s operating Instructions, observing all precautions and warnings. All safety guidelines within the air supply unit' s operating Instructions should be followed.INSTRUCTIONS FOR USE1. Transfer surfaces should be close together and equal height or a slightly lower destination surface.2. Air inlet pockets are located at the foot end of pad. Locate and insert air supply hose.3. Avoid having obstructions in path of transfer including lines and hoses 4. Hold onto handles during inflation.5. Move patient in a diagonal direction. head or feet end first until patient reaches destination and is centered.6. Raise side rails, disconnect t air hose and undo safety straps.7. Use appropriate turning and rolling technique to remove transfer mat from underneath patient."

PRESTIGE AMERITECH, LTD.

2018-04-10

PremierPro Air Transfer Mats - "ReusableINTENDED USE/ CONTRAINDICATIONSPrernierPro'"" Air Transfer Mats are indicated for patients• Who are unable to transfer or turn by their own effort. both assisted and unassisted• Whose size and weight present possible risks to caregivers involved in the transfer of the patientPRECAUTIONS & WARNINGS• Use two or more caregivers during patient transfers• Do not use transfer mat until user manual is reviewed.• Do not leave patient unattended on inflated transfer mat• Do not attempt to move patient on uninflated transfer mat.• The maximum safe working load for all PremierPro""' Air Transfer Mats is 1,000Ibs (450kg)AIR SUPPLYAir supply units may be compatible with PremierPro' "" Air Transfer Mats if they provide 3 psi pressure and 80 cfm capacity. The hose used may be a standard 1.75"" diameter hose that may be secured with a snap fastener or hook & loop fastener. Always refer the air supply unit’s operating Instructions, observing all precautions and warnings. All safety guidelines within the air supply unit' s operating Instructions should be followed.INSTRUCTIONS FOR USE1. Transfer surfaces should be close together and equal height or a slightly lower destination surface.2. Air inlet pockets are located at the foot end of pad. Locate and insert air supply hose.3. Avoid having obstructions in path of transfer including lines and hoses 4. Hold onto handles during inflation.5. Move patient in a diagonal direction. head or feet end first until patient reaches destination and is centered.6. Raise side rails, disconnect t air hose and undo safety straps.7. Use appropriate turning and rolling technique to remove transfer mat from underneath patient."

PRESTIGE AMERITECH, LTD.

2018-04-10

PremierPro Air Transfer Mats - "ReusableINTENDED USE/ CONTRAINDICATIONSPrernierPro'"" Air Transfer Mats are indicated for patients• Who are unable to transfer or turn by their own effort. both assisted and unassisted• Whose size and weight present possible risks to caregivers involved in the transfer of the patientPRECAUTIONS & WARNINGS• Use two or more caregivers during patient transfers• Do not use transfer mat until user manual is reviewed.• Do not leave patient unattended on inflated transfer mat• Do not attempt to move patient on uninflated transfer mat.• The maximum safe working load for all PremierPro""' Air Transfer Mats is 1,000Ibs (450kg)AIR SUPPLYAir supply units may be compatible with PremierPro' "" Air Transfer Mats if they provide 3 psi pressure and 80 cfm capacity. The hose used may be a standard 1.75"" diameter hose that may be secured with a snap fastener or hook & loop fastener. Always refer the air supply unit’s operating Instructions, observing all precautions and warnings. All safety guidelines within the air supply unit' s operating Instructions should be followed.INSTRUCTIONS FOR USE1. Transfer surfaces should be close together and equal height or a slightly lower destination surface.2. Air inlet pockets are located at the foot end of pad. Locate and insert air supply hose.3. Avoid having obstructions in path of transfer including lines and hoses 4. Hold onto handles during inflation.5. Move patient in a diagonal direction. head or feet end first until patient reaches destination and is centered.6. Raise side rails, disconnect t air hose and undo safety straps.7. Use appropriate turning and rolling technique to remove transfer mat from underneath patient."

PRESTIGE AMERITECH, LTD.

2018-04-10

PremierPro Air Trasnsfer - "AIR SUPPLYAir supply units may be compatible with PremierPro™ Air Transfer Mats if they provide 3 psi pressure and 80 cfm capacity. The hose used may be a standard 1.75"" diameter hose that may be secured with a snap fastener or hook & loop fastener. Always refer the air supply unit's operating instructions, observing all precautions and warnings. All safety guidelines within the air supply unit's operating instructions should be followed.MRI SAFETYPremierPro™ Air Transfer Mats may be used in situations that require transferring patients undergoing Magnetic Resonance Imaging (MRI). PremierPro™ Air Transfer Mats have been evaluated for use with MRI and have been determined to be safe for use. This conclusion is based on the following factors:Materials of construction for top and bottom fabrics include Nylon, PVC and Mesh.Safety strap buckles are constructed from Polypropylene.Air supply fasteners are manufactured from non-ferrous metal.Air supply fasteners are not in the radio frequency field or the field of imaging and will not cause artifacts.Evaluation of these factors indicates PremierPro™ Air Transfer Mats are safe when used with patients undergoing MRI.CLEANINGDisposable ModelsThe PremierPro™ Disposable Air Transfer Mat is not intended to be laundered and reused. Check Local, State and Federal Guidelines before disposing of this product."

PRESTIGE AMERITECH, LTD.

2018-04-10

PremierPro Air Transfer Mats - "INTENDED USE/ CONTRAINDICATIONSPremierPro™ Air Transfer Mats are indicated for patients:Who are unable to transfer or turn by their own effort, both assisted and unassisted.Whose size and weight present possible risks to caregivers involved in the transfer of the patient.PRECAUTIONS & WARNINGSUse two or more caregivers during patient transfers.Do not use transfer mat until user manual is reviewed.Do not leave patient unattended on inflated transfer mat.Do not attempt to move patient on uninflated transfer mat.The maximum safe working load for all PremierPro™ Air Transfer Mats is l,000lbs (450kg).AIR SUPPLYAir supply units may be compatible with Premier™ Air Transfer Mats if they provide 3 psi pressure and 80 cfm capacity. The hose used may be a standard 1.75"" diameter hose that may be secured with a snap fastener or hook & loop fastener. Always refer the air supply unit's operating instructions, observing all precautions and warnings. All safety guidelines within the air supply unit's operating instructions should be followed.MRI SAFETYPremierPro™ Air Transfer Mats may be used in situations that require transferring patients undergoing Magnetic Resonance Imaging (MRI). PremierPro™ Air Transfer Mats have been evaluated for use with MRI and have been determined to be safe for use. This conclusion is based on the following factors:Materials of construction for top and bottom fabrics include Nylon, PVC and Mesh.Safety strap buckles are constructed from Polypropylene.Air supply fasteners are manufactured from non-ferrous metal.Air supply fasteners are not in the radio frequency field or the field of imaging and will not cause artifacts.Evaluation of these factors indicates PremierPro™ Air Transfer Mats are safe when used with patients undergoing MRI.CLEANINGThe PremierPro™ Disposable Air Transfer Mat is not intended to be laundered and reused. Check Local, State and Federal Guidelines before disposing of this product."

PRESTIGE AMERITECH, LTD.

2018-04-10

PremierPro - Warming Blanket, Pre Warming Gown, Size Small plus Kit1. GENERAL DESCRIPTION · PremierPro™ Multi-functional Warming Blankets 2. CONSTRUCTION · Raw material: Multi-Laminate/ Heat Sealed or Stitched Non-woven Polypropylene fabric · Yellow / Non-Breathable Air Capture Layer – Coated / Low-density polyethylene (LDPE) · White (patient facing) Layer - Perforated to enable passage of air and temperature control · Disposable / Single Patient Use · Not made with natural rubber latex. 3. MRI COMPATIBLE · Non-Metallic / Disposable Patient Warming Blankets are compatible with Magnetic Resonance Imaging equipment The Warming System is indicated for hyper or hypothermic patients or normothermic patients for who induced hyper or hypothermia or localized temperature therapy is clinically indicated. In addition, the Warming System can be used to provide patient thermal comfort when conditions exist that may cause patients to become too cold or too warm.

PRESTIGE AMERITECH, LTD.

2019-04-05

PremierPro - Warming Blanket, Abdominal Access, 10/bg 1. GENERAL DESCRIPTION · PremierPro™ Multi-functional Warming Blankets 2. CONSTRUCTION · Raw material: Multi-Laminate/ Heat Sealed or Stitched Non-woven Polypropylene fabric · Yellow / Non-Breathable Air Capture Layer – Coated / Low-density polyethylene (LDPE) · White (patient facing) Layer - Perforated to enable passage of air and temperature control · Disposable / Single Patient Use · Not made with natural rubber latex. 3. MRI COMPATIBLE · Non-Metallic / Disposable Patient Warming Blankets are compatible with Magnetic Resonance Imaging equipment The Warming System is indicated for hyper or hypothermic patients or normothermic patients for who induced hyper or hypothermia or localized temperature therapy is clinically indicated. In addition, the Warming System can be used to provide patient thermal comfort when conditions exist that may cause patients to become too cold or too warm.

PRESTIGE AMERITECH, LTD.

2019-04-05

PremierPro - Warming Blanket, Adult Tube Underbody1. GENERAL DESCRIPTION · PremierPro™ Multi-functional Warming Blankets 2. CONSTRUCTION · Raw material: Multi-Laminate/ Heat Sealed or Stitched Non-woven Polypropylene fabric · Yellow / Non-Breathable Air Capture Layer – Coated / Low-density polyethylene (LDPE) · White (patient facing) Layer - Perforated to enable passage of air and temperature control · Disposable / Single Patient Use · Not made with natural rubber latex. 3. MRI COMPATIBLE · Non-Metallic / Disposable Patient Warming Blankets are compatible with Magnetic Resonance Imaging equipment The Warming System is indicated for hyper or hypothermic patients or normothermic patients for who induced hyper or hypothermia or localized temperature therapy is clinically indicated. In addition, the Warming System can be used to provide patient thermal comfort when conditions exist that may cause patients to become too cold or too warm.

PRESTIGE AMERITECH, LTD.

2019-04-05

PremierPro - Warming Blanket, Lower Body 100 x 120 cm1. GENERAL DESCRIPTION · PremierPro™ Multi-functional Warming Blankets 2. CONSTRUCTION · Raw material: Multi-Laminate/ Heat Sealed or Stitched Non-woven Polypropylene fabric · Yellow / Non-Breathable Air Capture Layer – Coated / Low-density polyethylene (LDPE) · White (patient facing) Layer - Perforated to enable passage of air and temperature control · Disposable / Single Patient Use · Not made with natural rubber latex. 3. MRI COMPATIBLE · Non-Metallic / Disposable Patient Warming Blankets are compatible with Magnetic Resonance Imaging equipment The Warming System is indicated for hyper or hypothermic patients or normothermic patients for who induced hyper or hypothermia or localized temperature therapy is clinically indicated. In addition, the Warming System can be used to provide patient thermal comfort when conditions exist that may cause patients to become too cold or too warm.

PRESTIGE AMERITECH, LTD.

2019-04-05

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