AFCS PEARLS™ Control unit 2010312

GUDID 08720387388127

Air-Fluidized bed - see www.synergiecare.com AFCS PEARLS™ (SAT2) transport supports

Synergie Nederland B.V.

Air-fluidized bed
Primary Device ID08720387388127
NIH Device Record Key18e1b9cb-7e01-4661-be54-5b038cdb0f52
Commercial Distribution StatusIn Commercial Distribution
Brand NameAFCS PEARLS™ Control unit
Version Model NumberSAT2
Catalog Number2010312
Company DUNS417294923
Company NameSynergie Nederland B.V.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108720387388127 [Primary]

FDA Product Code

INXBed, Air Fluidized

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-30
Device Publish Date2021-08-20

On-Brand Devices [AFCS PEARLS™ Control unit]

08720387388127Air-Fluidized bed - see www.synergiecare.com AFCS PEARLS™ (SAT2) transport supports
08720387388004Air-Fluidized bed - see www.synergiecare.com AFCS PEARLS™ (SAT2) Innovative care Control Unit

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