FDA UDI In Commercial Distribution 🇺🇸 United States

Prodigy Pressure Activated Safety Lancets

DI: 00384849903389 · Model: 990338 · Prodigy Diabetes Care, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100

Basic Information

Brand Name
Prodigy Pressure Activated Safety Lancets
Primary DI
00384849903389
Version / Model
990338
Catalog Number
990338
Company Name
Prodigy Diabetes Care, LLC
Labeler DUNS
832875905
Distribution Status
In Commercial Distribution
Device Count in Pkg
100
Record Status
Published
Publish Date
2018-08-21
Public Version
2
Public Version Date
2023-09-27
Public Version Status
Update
Public Device Record Key
a1298668-476a-4cb4-9fef-26ac9e08abba

Device Description

Prodigy Pressure Activated Safety Lancets 28G (100 ct)

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
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
Yes
Sterilization Prior Use
No

Product Codes

Code Name
FMK Lancet, Blood

GMDN Terms

Code Name
61578 Manual blood lancing device, single-use

Identifiers

Type ID
Package 30384849903380
Primary 00384849903389
Unit of Use 90384849903382