AccessGUDID - DEVICE: HemoPoint® H2 n•x•t Microcuvettes (00657498301654)

GUDID

Device Identifier (DI) Information

Brand Name: HemoPoint® H2 n•x•t Microcuvettes
Version or Model: 3016-050
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3016-050
Company Name: STANBIO LABORATORY, L.P.

Primary DI Number: 00657498301654
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 045361136 *Terms of Use

Device Description: For the quantitative determination of hemoglobin in capillary, venous or arterial 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:	Yes
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 [?]
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 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 45835534-4852-40e6-a8c9-156b3c04d3d5
Public Version Date: August 31, 2022
Public Version Number: 3
DI Record Publish Date: September 24, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
00657498000212	4	00657498301654		In Commercial Distribution	box
00657498000205	2	00657498301654		In Commercial Distribution	box
00657498002001	4	00657498301654	2022-08-30	Not in Commercial Distribution	box
00657498001998	2	00657498301654	2022-08-30	Not in Commercial Distribution	box