AccessGUDID - DEVICE: B Medical Systems (05450104537721)

GUDID

Device Identifier (DI) Information

Brand Name: B Medical Systems
Version or Model: PF260
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 991.8346.03
Company Name: B Medical Systems SARL

Primary DI Number: 05450104537721
Issuing Agency: GS1
Commercial Distribution End Date: February 10, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 377142935 *Terms of Use

Device Description: Pharmacy refrigerator/ freezer

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?
63326	Pharmacy refrigerator/freezer, mains-powered	A mains electricity (AC- or DC-powered) fridge/freezer designed for the storage of pharmaceutical products (e.g., medications, live virus vaccines), reagents and other related materials both at refrigerated temperatures (1 to 6 °C) and in a frozen state (-18 to -30 °C). It includes refrigeration and freezing compartments with internal shelving, controls, sensors and alarms to signal out-of-range temperatures and power failures; its interior is typically corrosion-resistant to minimize the risk of adulteration, contamination, and/or corrosion of contents. The refrigeration unit is typically equipped with a safety thermostat to protect the products from freezing.	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: 1b3fd244-2441-4629-a308-fef72a19b517
Public Version Date: December 08, 2021
Public Version Number: 3
DI Record Publish Date: September 27, 2018