FDA.report

MICROTEK

Primary DI
30748426074069
Brand
MICROTEK
Company
Microtek Medical Inc.
Model
1
Device description
MICROSHIELD PROTECTION PAK, 1-EACH
Published
2017-03-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
CBPValve, non-rebreathing

Product Code Classifications

CodeDeviceSpecialtyClass
CBPValve, Non-RebreathingAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30748426074069PackageGS110In Commercial Distribution
50748426074063PackageGS15In Commercial Distribution
00748426112739PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
3074842607406930748426074069
5074842607406350748426074063
00748426112739007484261127397484261127390748426112739

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.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store under normal warehouse conditions.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)824-3027customerservicemicrotekmed.com@ecolab.com

Regulatory Flags

DUNS number
106908437
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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30748426123569Cardinal HealthOrgan Bag29-100392024-09-26
50748426113748EcolabCoreTemp EquipmentCTW5L2023-11-30
50748426126731EcolabHush Slush EquipmentESW7L2023-11-16
08425921000502MICROTEK12018-08-29
18425921000530MICROTEK12018-08-29
18425921000578MICROTEK12018-08-29
18425921000592MICROTEK12018-08-29
18425921000615MICROTEK12018-08-29
18425921000639MICROTEK12018-08-29
00748426130092DePuy Synthes VELYS4515700184515-70-0182023-03-09
50748426130110DePuy Synthes VELYS4515700194515-70-0192023-03-09
30748426074946Microtek™9604UK9604UK2022-09-21
30748426132196CovidienPC-6X96PC-6X962022-08-16

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
B448FS1040Seal QuikFirstar Healthcare Company Limited (Guangzhou)CBP2025-12-10
16946430423013Lightning X Products, IncXIAMEN COMPOWER MEDICAL TECH. CO., LTDCBP2025-06-14
0503026716528522MM SMOOTHBORE EXHALATION VALVE BREATHING SYSTEM WITH MONITORING LINE AND SWIVEIntersurgical IncorporatedCBP2025-04-15
30889483570566AirLife™Sunmed Group Holdings, LLCCBP2025-03-28
16946430421941MENDYOUMEDICALXIAMEN COMPOWER MEDICAL TECH. CO., LTDCBP2024-11-26
00850055775022BIG EASY, NON-REBREATHING VALVEINNOVATION INSTITUTE, LLCCBP2024-10-30
0503026704086522MM SMOOTHBORE REUSABLE EXHALATION VALVE BREATHING SYSTEM. 1.6MIntersurgical IncorporatedCBP2024-09-16
09420012480149Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDCBP2024-09-11
04719871890011WNLFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
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