FDA UDI In Commercial Distribution 🇺🇸 United States

HeartsCare C1 URIC ACID TEST STRIPS(10PCS/BOX)

DI: 00850014861353 · Model: TD-4289 · Hearts Bio, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
HeartsCare C1 URIC ACID TEST STRIPS(10PCS/BOX)
Primary DI
00850014861353
Version / Model
TD-4289
Company Name
Hearts Bio, Inc.
Labeler DUNS
085509873
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-08-08
Public Version
1
Public Version Date
2023-08-16
Public Version Status
New
Public Device Record Key
fdcfedd6-5f8b-4562-815c-5e46c2446127

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
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
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
LFQ Acid, Uric, Acid Reduction Of Ferric Ion

GMDN Terms

Code Name
53586 Uric acid IVD, reagent

Identifiers

Type ID
Primary 00850014861353