FDA.report

CoverGuard

Primary DI
00845717012362
Brand
CoverGuard
Company
VERIDIAN HEALTHCARE LLC
Model
101-300T
Device description
CGM Patch,OmniPod5, Center-Cut, Tan, 25-Count
Published
2025-08-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
KGXTape And Bandage, Adhesive

Product Code Classifications

CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00845717012362PrimaryGS10

GMDN Terms

TermDefinition
Skin-cover adhesive strip, non-antimicrobialA small, narrow, flexible band (of fabric, plastic, paper, or other material) coated on one side with a pressure-sensitive adhesive and possibly with an absorbent pad, typically intended to cover a superficial wound or fix a dressing to skin. It may be hypoallergenic and/or waterproof, however it does not include antimicrobial agents/properties. Commonly referred to as a sticking plaster, it is intended for use in the home or a clinical setting. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
830437997
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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10845717013199SmartHeart UAM-710SH2025-12-12
00845717012096Trackstar302-2110B2025-09-15
30845717010130Veridian Healthcare11-50Q12025-09-09
00845717011785R.P.M. PRO210-1114B2025-09-08
00845717011945R.P.M. PRO210-3110B2025-09-08
00845717012164Trackstar302-1110B2025-09-08
00845717011068R.P.M. PRO210-1113B2025-09-02
00845717011938R.P.M. PRO210-1113C2025-09-02
00845717012102Trackstar302-1113B2025-09-02
00845717012195Trackstar302-1114B2025-09-02
00845717012287CoverGuard101-100T2025-08-15
00845717012294CoverGuard101-101T2025-08-15
00845717012300CoverGuard101-100B2025-08-15
00845717012317CoverGuard101-101B2025-08-15
00845717012324CoverGuard101-200T2025-08-15
00845717012331CoverGuard101-201T2025-08-15
00845717012348CoverGuard101-200B2025-08-15
00845717012355CoverGuard101-201B2025-08-15
00845717012379CoverGuard101-300T2025-08-15
00845717012386CoverGuard101-300B2025-08-15

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