Thoraguard

FDA UDI

Class I (US FDA UDI)

by Centese, Inc.

Identity

Trade Name: Thoraguard FDA UDI
Generic Name: Mediastinal drainage catheter, non-antimicrobial FDA UDI
Device Name: Thoraguard Chest Tube Kit, 28 Fr FDA UDI
Model / Reference: FGS-2000 FDA UDI
Description: Thoraguard Chest Tube Kit, 28 Fr FDA UDI

Identifiers

Catalog Number: TGCT120028 FDA UDI
Primary DI / UDI-DI: 00860000436441 FDA UDI
FDA Product Code: GBX FDA UDI
GMDN Term: Mediastinal drainage catheter, non-antimicrobial 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

Yes

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

MRI Safety

MR Unsafe FDA UDI

Dimensions & Sizes

Size: Catheter Gauge — 28 French FDA UDI

Category: Pleural catheter Sump drain Mediastinal drainage catheter, non-antimicrobial

Thoraguard by Centese, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Sump drain.

Salem Sump — Cardinalhealth · Class II
Salem Sump — Cardinalhealth · Class II
Salem Sump — Cardinalhealth · Class II
MedDrain — ARMM INC. · Class I
Axiom® Interpleural Anesthesia — AXIOM MEDICAL, INCORPORATED · Class II
Salem Sump — Cardinal Health 200, LLC · Class II
Axiom® Dual-Sump Atraum™ With ClotStop® — AXIOM MEDICAL, INCORPORATED · Class I
Axiom® Uni-Sump — AXIOM MEDICAL, INCORPORATED · 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: Centese, Inc.

Sources (1)

FDA UDI ce594f79-5e82-4775-9cf9-c65b5076d79a 36 fields · synced May 30, 2026