FDA UDI In Commercial Distribution 🇺🇸 United States

FINDER

DI: 00819704020333 · Model: 3409 · Baebies, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
FINDER
Primary DI
00819704020333
Version / Model
3409
Company Name
Baebies, Inc.
Labeler DUNS
079264306
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-01-31
Public Version
2
Public Version Date
2026-04-08
Public Version Status
Update
Public Device Record Key
5de814a7-374c-4e5c-92cd-6007587afc26

Device Description

FINDER Instrument

Device Characteristics

Single Use
No
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
No
Has Serial Number
Yes
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
JBF Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening

GMDN Terms

Code Name
62181 Multiple clinical chemistry analyser IVD, point-of-care

Identifiers

Type ID
Primary 00819704020333

Customer Contacts

Premarket Submissions

Submission Number Supplement Number
K201049 000