AccessGUDID - DEVICE: Add Pack Hemo Control DM (04048534002189)

GUDID

Device Identifier (DI) Information

Brand Name: Add Pack Hemo Control DM
Version or Model: 3040-7201-0099
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3040-7201-0099
Company Name: EKF-diagnostic GmbH

Primary DI Number: 04048534002189
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 330046442 *Terms of Use

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
KHG	Whole Blood Hemoglobin Determination

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 64ab4269-f31f-47f4-85ed-d628f8f72f51
Public Version Date: December 29, 2022
Public Version Number: 1
DI Record Publish Date: December 21, 2022