Exodus

FDA UDI

Class II (US FDA UDI)

by Navilyst Medical, Inc.

Identity

Trade Name: Exodus FDA UDI
Generic Name: Closed-wound drain, non-bioabsorbable FDA UDI
Device Name: Array Multipurpose Drainage Catheter 10F x 35cm with Tight Pigtail FDA UDI
Model / Reference: 10512 FDA UDI
Description: Array Multipurpose Drainage Catheter 10F x 35cm with Tight Pigtail FDA UDI

Identifiers

Primary DI / UDI-DI: H965105120 FDA UDI
510(k) Number: K152069 FDA UDI
FDA Product Code: FGE FDA UDI
GMDN Term: Closed-wound drain, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.5010 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 3.4 Millimeter FDA UDI
Catheter Gauge — 10 French FDA UDI
Length — 35 Centimeter FDA UDI

Category: Closed-wound drain, non-bioabsorbable

Exodus by Navilyst Medical, Inc. — Class II — 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
One-Step™ — Merit Medical Systems, Inc. · Class I

Cleared under the same submission

K152069 also covers:

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 II	Pending data

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Manufacturer

Manufacturer: Navilyst Medical, Inc.

Sources (1)

FDA UDI d4ea2d0d-b17a-44ba-a2a0-1efbdbf42ceb 36 fields · synced May 30, 2026