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ThevoCalm FR 308 lbs, Split King 38 x 79", Inco

FDA UDI

Class I (US FDA UDI)

by Thomas Hilfen für Körperbehinderte GmbH & Co. Medico Kommanditgesellschaft

Identity

Trade Name
ThevoCalm FR 308 lbs, Split King 38 x 79", Inco FDA UDI
Generic Name
Orthopaedic bed mattress FDA UDI
Model / Reference
9800673140014 FDA UDI

Identifiers

Primary DI / UDI-DI
04034089064666 FDA UDI
FDA Product Code
IKY FDA UDI
GMDN Term
Orthopaedic bed mattress FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.5150 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

No

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Orthopaedic bed mattress

ThevoCalm FR 308 lbs, Split King 38 x 79", Inco by Thomas Hilfen für Körperbehinderte GmbH & Co. Medico Kommanditgesellschaft — Class I — FDA UDI — listed in…

Similar devices

Also classified as Orthopaedic bed mattress.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 8c210b76-9c26-48af-b5cb-9cfebd17b271 32 fields · synced Jun 6, 2026