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ManaMed Inc

FDA UDI

Class I (US FDA UDI)

by Manamed Llc

Identity

Trade Name
ManaMed Inc FDA UDI
Generic Name
Multifunction body cushion FDA UDI
Device Name
Replacement abduction pillow used to keep shoulder aligned with sling. FDA UDI
Model / Reference
Kahuna Pillow FDA UDI
Description
Replacement abduction pillow used to keep shoulder aligned with sling. FDA UDI

Identifiers

Catalog Number
KB001-P FDA UDI
Primary DI / UDI-DI
00810113682648 FDA UDI
FDA Product Code
IMP FDA UDI
GMDN Term
Multifunction body cushion FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.3920 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

Yes

FDA UDI

Category: Multifunction body cushion

ManaMed Inc by Manamed Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multifunction body cushion.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Manamed Llc

Sources (1)

  • FDA UDI dffb70f8-c19b-4336-8e04-05891ce55eaf 35 fields · synced May 30, 2026