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Guardian

FDA UDI

Class II (US FDA UDI)

by Turncare, Inc.

Identity

Trade Name
Guardian FDA UDI
Generic Name
Alternating-pressure chair cushion, reusable FDA UDI
Device Name
Guardian System Seat Enhancer-70", integrated tube connector FDA UDI
Model / Reference
GS-EN-ST-70 FDA UDI
Description
Guardian System Seat Enhancer-70", integrated tube connector FDA UDI

Identifiers

Catalog Number
GS-EN-ST-70 FDA UDI
Primary DI / UDI-DI
00860008160386 FDA UDI
FDA Product Code
FNM FDA UDI
GMDN Term
Alternating-pressure chair cushion, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5550 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

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Alternating-pressure chair cushion, reusable

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

Similar devices

Also classified as Alternating-pressure chair cushion, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Turncare, Inc.

Sources (1)

  • FDA UDI cc4f5da5-0945-4d64-a6af-c33d57b3797a 34 fields · synced May 30, 2026