Navarre Opti-Drain

FDA UDI

Class I (US FDA UDI)

by Bard Access Systems, Inc.

Identity

Trade Name: Navarre Opti-Drain FDA UDI
Generic Name: Closed-wound drain, non-bioabsorbable FDA UDI
Device Name: Navarre Opti-Drain Multi-Use Drainage Catheter, J-Curve, 12 Fr x 30 cm FDA UDI
Model / Reference: NOD12J FDA UDI
Description: Navarre Opti-Drain Multi-Use Drainage Catheter, J-Curve, 12 Fr x 30 cm FDA UDI

Identifiers

Catalog Number: NOD12J FDA UDI
Primary DI / UDI-DI: 00801741037054 FDA UDI
FDA Product Code: GBX FDA UDI
GMDN Term: Closed-wound drain, non-bioabsorbable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4200 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Catheter Gauge — 12 French FDA UDI
Length — 30 Centimeter FDA UDI

Category: Closed-wound drain, non-bioabsorbable

Navarre Opti-Drain by Bard Access Systems, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Closed-wound drain, non-bioabsorbable.

Argyle — Cardinal Health 200, LLC · Class II
ReSolve® — Merit Medical Systems, Inc. · Class I
One-Step™ — Merit Medical Systems, Inc. · Class I
Argyle — Cardinal Health 200, LLC · Class II
Silicone Vac Drain, Round — FORTUNE MEDICAL INSTRUMENT CORP. · Class IIa
SKATER™ Mini-Loop Drainage Set — Argon Medical Devices, Inc. · Class I
Drainage Tube and Accessories — Hangzhou Fushan Medical Appliances Co., Ltd. · Class IIa
Exodus — NAVILYST MEDICAL, INC. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Bard Access Systems, Inc.

Sources (1)

FDA UDI be7d466b-0607-457c-8502-60357e0438d3 36 fields · synced Jun 9, 2026