AccessGUDID - DEVICE: B Medical Systems (05450104503429)

GUDID

Device Identifier (DI) Information

Brand Name: B Medical Systems
Version or Model: ML355S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 991.6737.**
Company Name: B Medical Systems SARL

Primary DI Number: 05450104503429
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 377142935 *Terms of Use

Device Description: Laboratory 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?
17157	Laboratory refrigerator, basic	A mains electricity (AC-powered) refrigerator specially designed to maintain the cold temperatures required for the storage of samples, specimens, cultures, and other laboratory preparations. It will typically have a corrosion resistant (e.g., stainless steel) interior to minimize the risk of adulteration, contamination, and/or corrosion of contents; include a glass door and internal shelving for easy set-up of instrumentation and chromatography devices within the chamber. It will typically include sensors, controls and monitors, forced-air circulation and a built-in alarm system that warns against unexpected temperature variations as well as a recorder to record events.	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: 17721cb9-f24f-4179-9242-63a36f37cd5d
Public Version Date: February 19, 2020
Public Version Number: 1
DI Record Publish Date: February 11, 2020