FDA.report

TMM-PPE, Advanced

Primary DI
00856767008229
Brand
TMM-PPE, Advanced
Company
Chinook Medical Gear
Model
01457
Catalog number
01457
Device description
Chinook designed TMM-PPE Kit, Advanced (Tactical Medical Module-Personal Protective Equipment Kit, Advanced) with clothing and gear to provide barriers between you and a patient thus helping to prevent the spread of infection or illness. This kit contains the essential items necessary to protect your hands, clothes, face and lungs from splattered body fluids and airborne particles.
Published
2019-06-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
OHOFirst Aid Kit Without Drug

Product Code Classifications

CodeDeviceSpecialtyClass
OHOFirst Aid Kit Without DrugGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00856767008229PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00856767008229008567670082298567670082290856767008229

GMDN Terms

TermDefinition
Surgical/medical face mask, single-useA flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials) during medical procedures and patient examination; it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or transparent face/eye visor intended to protect the upper face/eyes from debris/fluid. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
621904622
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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