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Thoraguard

FDA UDI

Class II (US FDA UDI)

by Centese, Inc.

Identity

Trade Name
Thoraguard FDA UDI
Generic Name
Thoracic suction pump FDA UDI
Device Name
Thoraguard Control Module FDA UDI
Model / Reference
FGN-1387 FDA UDI
Description
Thoraguard Control Module FDA UDI

Identifiers

Catalog Number
TGCM1000 FDA UDI
Primary DI / UDI-DI
00860000436427 FDA UDI
510(k) Number
K181667 FDA UDI
FDA Product Code
BTA FDA UDI
GMDN Term
Thoracic suction pump FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4780 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Thoracic suction pump

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

Similar devices

Also classified as Thoracic suction pump.

Cleared under the same submission

K181667 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Centese, Inc.

Sources (1)

  • FDA UDI 5ab5e631-8ba4-4cf5-8866-47800eaf15ae 36 fields · synced Jun 8, 2026