FDA.report

SILICONE CUSHION MASK SIZE#4

Primary DI
04716770862415
Brand
SILICONE CUSHION MASK SIZE#4
Company
BESMED HEALTH BUSINESS CORP.
Model
SM-86241
Device description
SILICONE CUSHION MASK SIZE#4
Published
2017-12-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
KGBMask, Oxygen, Non-Rebreathing

Product Code Classifications

CodeDeviceSpecialtyClass
KGBMask, Oxygen, Non-RebreathingAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04716770862415PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04716770862415047167708624154716770862415

GMDN Terms

TermDefinition
Cardiopulmonary resuscitation mask, reusableA flexible, form-shaped device that is placed over a patient's mouth to administer "mouth-to-mask" exhaled air from the user to the patient during cardiopulmonary resuscitation (CPR). The device is designed to replace "mouth-to-mouth" resuscitation therefore reducing the risk of cross-contamination; it is also used on manikins by students during CPR training. The device typically consists of the mask with a mouthpiece and a non-rebreathing valve and/or bacteria filter. Also referred to as a pocket face mask, it is typically used by emergency medical services (EMS). This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
658023775
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

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04716770701158Angled HME with luer lock portFL-701152026-02-11
04716770702230Bacterial Filter (Dead space 32ml)FL-702232026-02-11
14716770703029HMEF W/Luer lock port (Dead space 45ml)FL-703022026-02-11
14716770703036HMEF W/Luer lock port (Dead space 60ml)FL-703032026-02-11
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04716770834221ICU gas sampling packOT-834222022-08-08
04716770834238ICU gas sampling pack with flowmeterOT-834232022-08-08
04716770144306Straight Connector 15F/22M, 15M W/PORT & CAPCT-143302021-01-07
04716770857398FLOW SENSOR, ADULTPO-857392021-01-07
04716770790015Elbow connetor 18MM ID for nebulizerMP-790012017-12-13
04716770791043MOUTH PIECE (OD:18mm,22mm)MP-791042017-12-13
04716770791081MOUTH PIECE(OD:22mm)MP-791082017-12-13
04716770791098MOUTH PIECE (ID:18mm, OD:19.5mm)MP-791092017-12-13
04716770791203Nebulizer,pacifierMP-791202017-12-13
04716770000176SILICONE ADULT 1000ML RESUSCITATOR W/ POP-OFF 60CM H2O, L TYPE ADAPTERRE-231722016-05-23
04716770000183 SINGLE USE ADULT 1000ML RESUSCITATOR W/O POP-OFFRE-234122016-05-23
04716770000190 SINGLE USE CHILD 500ML RESUSCITATOR W/ POP-OFF 40CM H2O (ALL IN ONE-INTAKE VALVRE-245102016-05-23
04716770244372SINGLE USE ADULT RESUSCITATOR BALL 1600ML W/POP-OFF , 60cm H2O & MANOMETER PORTRE-244372016-05-23
04716770005607Digital tens one channelBE-5602016-09-07

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