Setmark Incorporated

FDA UDI

Class II (US FDA UDI)

by Setmark Inc.

Identity

Trade Name: Setmark Incorporated FDA UDI
Generic Name: Hospital stretcher, manual FDA UDI
Device Name: Aluminum Stretcher w/5' casters w/ Medical grade plastic top FDA UDI
Model / Reference: TR-148 FDA UDI
Description: Aluminum Stretcher w/5' casters w/ Medical grade plastic top FDA UDI

Identifiers

Primary DI / UDI-DI: 00865388000444 FDA UDI
FDA Product Code: FPO FDA UDI
GMDN Term: Hospital stretcher, manual FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.6910 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Hospital stretcher, manual

Setmark Incorporated by Setmark Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hospital stretcher, manual.

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MJM WOODTONE LINE — MJM International Corporation · Class II
COMPLETE TRANSPORT STRETCHER — Mac Medical, Inc. · Class II
Sprint 100 — L I N E T spol. s r.o. · Class II
PERSONAL TRANSPORT STRETCHER W ITH HEAD REST — Mac Medical, Inc. · Class II
Prime — Stryker Corp. · 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

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Manufacturer

Manufacturer: Setmark Inc.

Sources (1)

FDA UDI 48e8e8d3-0133-4e42-8ab5-32a83d29dd07 33 fields · synced Jun 8, 2026