AccessGUDID - DEVICE: DiaSpect Tm (04048534002165)

GUDID

Device Identifier (DI) Information

Brand Name: DiaSpect Tm
Version or Model: 7049-0013-0264
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 900-001
Company Name: EKF-diagnostic GmbH

Primary DI Number: 04048534002165
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 330046442 *Terms of Use
Previous DI: 04048534001946

Device Description: For the quantitative determination of hemoglobin in whole blood.

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?
32435	Haemoglobin analyser IVD, point-of-care	A mains electricity (AC-powered) instrument, which may include internal rechargeable batteries, intended to be used by health professionals at the point-of-care, and often also in the laboratory, to determine the concentration of haemoglobin in a clinical specimen, using technology which may include colorimetry, electrometry or photometry.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GKR	System, Hemoglobin, Automated

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK200520	0

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 0 and 50 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: 96e5af96-520b-4776-b98f-28366623f4f2
Public Version Date: October 25, 2022
Public Version Number: 1
DI Record Publish Date: October 17, 2022