Platinum 6000 Control Unit

FDA UDI

Class I (US FDA UDI)

by Sizewise Rentals, L.l.c.

Identity

Trade Name: Platinum 6000 Control Unit FDA UDI
Generic Name: Alternating-pressure inflator FDA UDI
Device Name: 61600050 FDA UDI
Model / Reference: PLATB FDA UDI
Description: 61600050 FDA UDI

Identifiers

Primary DI / UDI-DI: 00845699001149 FDA UDI
FDA Product Code: FMR FDA UDI
GMDN Term: Alternating-pressure inflator FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 880.6785 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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Alternating-pressure inflator

Platinum 6000 Control Unit by Sizewise Rentals, L.l.c. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 I	Pending data

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Manufacturer

Manufacturer: Sizewise Rentals, L.l.c.

Sources (1)

FDA UDI 04401842-8af5-47f6-a43c-ca90075d8b5a 33 fields · synced Jun 8, 2026