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AFCS PEARLS™ Extension Hose

FDA UDI

Class II (US FDA UDI)

by Synergie Nederland B.V.

Identity

Trade Name
AFCS PEARLS™ Extension Hose FDA UDI
Generic Name
Air-fluidized bed FDA UDI
Device Name
Air-Fluidized bed - see www.synergiecare.com Extension hose to place the control unit seperate from the bed unit FDA UDI
Model / Reference
SAT2 FDA UDI
Description
Air-Fluidized bed - see www.synergiecare.com Extension hose to place the control unit seperate from the bed unit FDA UDI

Identifiers

Catalog Number
2010310-US FDA UDI
Primary DI / UDI-DI
08720387388028 FDA UDI
FDA Product Code
INX FDA UDI
GMDN Term
Air-fluidized bed FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.5160 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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Air-fluidized bed

AFCS PEARLS™ Extension Hose by Synergie Nederland B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Air-fluidized bed.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Synergie Nederland B.V.

Sources (1)

  • FDA UDI 7b3e8f79-4bd9-4f56-9c07-0945ef38c217 34 fields · synced Jun 8, 2026