AccessGUDID - DEVICE: Roberts Oxygen Co. Inc. (B939CROC97910)

GUDID

Device Identifier (DI) Information

Brand Name: Roberts Oxygen Co. Inc.
Version or Model: CROC-9791
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CROC-9791
Company Name: Western Enterprises

Primary DI Number: B939CROC97910
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 148634731 *Terms of Use

Device Description: NEXTGEN 3/4-16 CONN ROBERTS O2

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):	Yes
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?
60970	Fixed medical gas cylinder regulator	A gas-regulating component of a medical gas (e.g., carbon dioxide, oxygen, nitrous oxide, gas mixture) cylinder to reduce high, variable gas pressure to a lower, constant working pressure. It typically includes a cylinder shut-off switch (i.e., cylinder valve), regulator controls, manometer(s), a refill port, and a safety relief valve to avoid excessive pressure due to increased ambient temperatures. It is intended to be permanently fitted by a manufacturer to the stem of a valveless (i.e., open) empty medical gas cylinder prior to filling.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAN	Regulator, Pressure, Gas Cylinder

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: ef202a61-5b28-4a0b-8d52-f248a7249d7f
Public Version Date: January 15, 2025
Public Version Number: 1
DI Record Publish Date: January 07, 2025