AccessGUDID - DEVICE: B Medical Systems (05450104532412)

GUDID

Device Identifier (DI) Information

Brand Name: B Medical Systems
Version or Model: PR750G
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 991.6657.54
Company Name: B Medical Systems SARL

Primary DI Number: 05450104532412
Issuing Agency: GS1
Commercial Distribution End Date: February 11, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 377142935 *Terms of Use

Device Description: Pharmacy refrigerator

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":	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?
17156	Pharmacy refrigerator	A mains electricity (AC-powered) refrigerator specially designed for cool storage of pharmaceuticals, e.g., medications or live virus vaccines. It may be provided with a built-in alarm system that warns against unexpected temperature variations.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JRM	Freezer

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
Handling Environment Temperature: between -30 and 70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f85448ce-9b79-4964-a347-99ed22447a2d
Public Version Date: February 12, 2020
Public Version Number: 2
DI Record Publish Date: September 27, 2018