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TubeClear

FDA UDI

Class II (US FDA UDI)

by Actuated Medical, Inc.

Identity

Trade Name
TubeClear FDA UDI
Generic Name
Enteral feeding/decompression tube clearing stem FDA UDI
Device Name
Clearing Stem FDA UDI
Model / Reference
TC-1018 FDA UDI
Description
Clearing Stem FDA UDI

Identifiers

Primary DI / UDI-DI
00850458007621 FDA UDI
510(k) Number
K163092 FDA UDI
FDA Product Code
KNT FDA UDI
GMDN Term
Enteral feeding/decompression tube clearing stem FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5980 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Enteral feeding/decompression tube clearing stemEnteral feeding/decompression tube clearing actuator

TubeClear by Actuated Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Enteral feeding/decompression tube clearing actuator.

Cleared under the same submission

K163092 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Actuated Medical, Inc.

Sources (1)

  • FDA UDI 542caa25-2836-4dcb-8874-0b90feb9982d 34 fields · synced May 30, 2026