AccessGUDID - DEVICE: SAHARA-III MAXITHERM 115V (04038917968645)

GUDID

Device Identifier (DI) Information

Brand Name: SAHARA-III MAXITHERM 115V
Version or Model: 97.8710.802
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 97.8710.802
Company Name: Sarstedt Aktiengesellschaft & Co.KG

Primary DI Number: 04038917968645
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 388000270 *Terms of Use

Device Description: No description.

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?
43434	Cryopreserved blood/tissue thawing unit	An electrically-powered device intended to be used to thaw, in a controlled manner, frozen units of whole blood, blood components (e.g., blood cells, plasma), and/or other biological tissues contained in storage cryobags. The device is typically programmable and can use a number of heating methods to achieve thawing (e.g., dry heat, microwave oven, water bath); it may provide agitation and be able to detect when thawing has been completed.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KZL	DEVICE, WARMING. BLOOD AND PLASMA

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK010045	000

Device Exempt from Premarket Submission: No 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: 3fad0611-c339-459d-92ef-50b066bbc4a5
Public Version Date: December 04, 2023
Public Version Number: 2
DI Record Publish Date: June 06, 2023