AccessGUDID - DEVICE: Assembly Required Distributors (00854362008200)

GUDID

Device Identifier (DI) Information

Brand Name: Assembly Required Distributors
Version or Model: ACM1502-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Assembly Required Distributors Inc

Primary DI Number: 00854362008200
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 170562396 *Terms of Use

Device Description: O2 tank holder only, stainless steel, 'E' tanks

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
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?
38753	Wheelchair medical gas supply holder	A container or bracket attached to a wheelchair used to hold the wheelchair occupant's medical gas supply (e.g., cylinder of oxygen).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNO	Accessories, Wheelchair

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: a66ee114-9e67-459d-bae6-20e497e4fb8e
Public Version Date: October 04, 2023
Public Version Number: 2
DI Record Publish Date: March 21, 2018