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Guardiva

FDA UDI

Class U (US FDA UDI)

by Bard Access Systems, Inc.

Identity

Trade Name
GUARDIVA FDA UDI
Generic Name
Percutaneous catheter protector, professional FDA UDI
Device Name
GUARDIVA 1IN/ 1-1/2MM STERILE FDA UDI
Model / Reference
FP-22-AD004 FDA UDI
Description
GUARDIVA 1IN/ 1-1/2MM STERILE FDA UDI

Identifiers

Catalog Number
FP-22-AD004 FDA UDI
Primary DI / UDI-DI
10801741085809 FDA UDI
FDA Product Code
FRO FDA UDI
GMDN Term
Percutaneous catheter protector, professional FDA UDI

Classification

Device Class
U FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Lumen/Inner Diameter — 1.5 Millimeter FDA UDI
Outer Diameter — 25 Millimeter FDA UDI

Category: Percutaneous catheter protector, professional

Guardiva by Bard Access Systems, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Percutaneous catheter protector, professional.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bard Access Systems, Inc.

Sources (1)

  • FDA UDI 6c092d35-7a18-4f2b-b2b6-6fc9b404c525 36 fields · synced Jun 9, 2026