FDA UDI Not in Commercial Distribution 🇺🇸 United States

HemoCue® 801 Connect

DI: 07311091391681 · Model: 139168 · Hemocue AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
HemoCue® 801 Connect
Primary DI
07311091391681
Version / Model
139168
Catalog Number
139168
Company Name
Hemocue AB
Labeler DUNS
356164426
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-04-25
Public Version
5
Public Version Date
2022-03-22
Public Version Status
Update
Public Device Record Key
02ad6600-8af0-4a6b-ab7e-00af877062f8
Distribution End Date
2020-12-02

Device Description

HemoCue® 801 Connect

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
JQP Calculator/Data Processing Module, For Clinical Use

GMDN Terms

Code Name
43472 Laboratory instrument/analyser application software IVD

Identifiers

Type ID
Primary 07311091391681