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CareGuard® 1198-48

by Diversatek Healthcare

CareGuard® 1198-48 is a Class I device made by Diversatek Healthcare, listed in FDA GUDID since 17 Sep 2016 (UDI-DI M7831198480), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberM7831198480 UDI-DI Date17 Sep 2016ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
CareGuard®
Generic name
Endoscopic bite block, basic, single-use
Model / Ref / Catalog
1198-48
Primary DI / UDI-DI
M7831198480
FDA product code
MNK
GMDN term
Endoscopic bite block, basic, single-use
Device class
Class I
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution
Size
Lumen/Inner Diameter — 16 Millimeter

Related devices

Category: Endoscopic bite block, basic, single-use

Similar devices in this category

Other devices filed under Endoscopic bite block, basic, single-use.

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Properties

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)