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Bardia

FDA UDI

Class II (US FDA UDI)

by C. R. Bard, Inc.

Identity

Trade Name
Bardia FDA UDI
Generic Name
Indwelling urethral drainage balloon catheter, non-antimicrobial FDA UDI
Device Name
Bardia Silicone Elastomer Coated Foley Catheter FDA UDI
Model / Reference
123516CE FDA UDI
Description
Bardia Silicone Elastomer Coated Foley Catheter FDA UDI

Identifiers

Catalog Number
123516CE FDA UDI
Primary DI / UDI-DI
00801741171680 FDA UDI
FDA Product Code
EZC FDA UDI
GMDN Term
Indwelling urethral drainage balloon catheter, non-antimicrobial FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5130 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

Yes

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
Total Volume — 5 Milliliter FDA UDI
Catheter Gauge — 16 French FDA UDI

Category: Indwelling urethral drainage balloon catheter, non-antimicrobial

Bardia by C. R. Bard, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Indwelling urethral drainage balloon catheter, non-antimicrobial.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
C. R. Bard, Inc.

Sources (1)

  • FDA UDI 4dfd906f-c8f4-412e-ac85-a37eb4243e5b 37 fields · synced May 31, 2026