Skip to content

Prodigy AutoCode Blood Glucose Monitoring System 051880-S

by Prodigy Diabetes Care, LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00384841518802 UDI-DI Date13 Aug 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Prodigy AutoCode Blood Glucose Monitoring System
Generic Name
Manual blood lancing device, reusable
Model / Ref / Catalog
051880-S
Primary DI / UDI-DI
00384841518802
510(k) Number
FDA Product Code
JJT, FMI, JJX, CGA, NBW
GMDN Term
Manual blood lancing device, reusable
Device Class
Class I
Regulation Number
862.1660, 880.5570, 862.1345
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K073118)

Other devices from Prodigy Diabetes Care, LLC

See all devices from Prodigy Diabetes Care, LLC →

Properties

  • Over-the-Counter
  • Combination Product
  • Lot / Batch Number
  • Serial Number
  • Expiration Date

Other properties (9)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • HCT/P: No
  • Premarket Exempt: No
  • Manufacturing Date: No