Abthera™

FDA UDI

Class II (US FDA UDI)

by Kci Usa, Inc.

Identity

Trade Name: ABTHERA™ FDA UDI
Generic Name: Negative-pressure wound therapy tubing set FDA UDI
Device Name: Abthera Tubing Set FDA UDI
Model / Reference: 370642 FDA UDI
Description: Abthera Tubing Set FDA UDI

Identifiers

Primary DI / UDI-DI: 00849554001275 FDA UDI
FDA Product Code: OMP FDA UDI
GMDN Term: Negative-pressure wound therapy tubing set 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

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

MRI Safety

MR Conditional FDA UDI

Category: Negative-pressure wound therapy tubing set

Abthera™ by Kci Usa, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Negative-pressure wound therapy tubing set.

Basic Series StingRay Suction Bell — Pensar Medical, LLC · Class II
Avance — Mölnlycke Health Care AB · Class II
RENASYS® Y-Connector — Smith & Nephew Medical, Ltd. · Class II
MicroDoc Mini Stingray and Drape Set — Pensar Medical, LLC · Class II
Advanced Series StingRay Suction Bell — Pensar Medical, LLC · Class II
DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
Mini StingRay — Pensar Medical, LLC · Class II
DeRoyal — DEROYAL INDUSTRIES, 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 II	Pending data

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

Manufacturer

Manufacturer: Kci Usa, Inc.

Sources (1)

FDA UDI 521c503b-21a5-4ddd-899a-19d17a3dff40 33 fields · synced Jun 8, 2026