AccessGUDID - DEVICE: DiaSpect Control Pack HBT2 (04048534001564)

GUDID

Device Identifier (DI) Information

Brand Name: DiaSpect Control Pack HBT2
Version or Model: 90B.0012
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: DiaSpect Medical GmbH

Primary DI Number: 04048534001564
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 3
Labeler D-U-N-S® Number*: 341050309 *Terms of Use

Device Description: For the verification of the precision and accuracy of DiaSpect Hemoglobin Analyzer and DiaSpect Hemoglobin Cuvettes

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):	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?
55874	Total haemoglobin (totHb) IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of total haemoglobin (totHb) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GGM	Control, Hemoglobin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Storage Environment Temperature: between 2 and 25 Degrees Celsius
Special Storage Condition, Specify: Temperatures of -30°C up to +70°C temporarily permitted during transport (24 hrs max.)

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 60835470-ba7f-4cf2-8338-48dc8fa8c218
Public Version Date: December 28, 2022
Public Version Number: 1
DI Record Publish Date: December 20, 2022