AccessGUDID - DEVICE: TMM-PPE, Advanced (00856767008229)

GUDID

Device Identifier (DI) Information

Brand Name: TMM-PPE, Advanced
Version or Model: 01457
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 01457
Company Name: Altitude Technologies Inc.

Primary DI Number: 00856767008229
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 621904622 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35177	Surgical/medical face mask, single-use	A 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.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
OHO	First Aid Kit Without Drug

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1afd06a9-edda-44e2-a355-7a38d6bd41bf
Public Version Date: June 13, 2023
Public Version Number: 3
DI Record Publish Date: June 27, 2019