AFCS PEARLS™ Backrest 2010316

GUDID 08720387388141

Air-Fluidized bed - see www.synergiecare.com AFCS PEARLS™ (SAT2) Air permeable backrest (manually adjustable)

Synergie Nederland B.V.

Freestanding patient positioner, reusable

• Primary Device ID: 08720387388141
• NIH Device Record Key: a06bc7b4-030d-4561-b6df-21f3e68a1504
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AFCS PEARLS™ Backrest
• Version Model Number: SAT2
• Catalog Number: 2010316
• Company DUNS: 417294923
• Company Name: Synergie Nederland B.V.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08720387388141 [Primary]

FDA Product Code

• INX: Bed, Air Fluidized

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-30
• Device Publish Date: 2021-08-20

Devices Manufactured by Synergie Nederland B.V.

• 08720387388004 - AFCS PEARLS™ Control unit: 2021-08-30 Air-Fluidized bed - see www.synergiecare.com AFCS PEARLS™ (SAT2) Innovative care Control Unit
• 08720387388011 - AFCS PEARLS™ Bed unit: 2021-08-30 Air-Fluidized bed - see www.synergiecare.com AFCS PEARLS™ (SAT2) Innovative care Bed/Frame
• 08720387388028 - AFCS PEARLS™ Extension Hose: 2021-08-30 Air-Fluidized bed - see www.synergiecare.com Extension hose to place the control unit seperate from the bed unit
• 08720387388035 - AFCS PEARLS™ Air filter: 2021-08-30 Air-Fluidized bed - see www.synergiecare.com AFCS PEARLS™ (SAT2) Air filter
• 08720387388042 - AFCS PEARLS™ Filter sheet large multifilament: 2021-08-30 Air-Fluidized bed - see www.synergiecare.com AFCS PEARLS™ (SAT2) Filter sheet large multifilament
• 08720387388059 - AFCS PEARLS™ Filter sheet small multifilament: 2021-08-30 Air-Fluidized bed - see www.synergiecare.com AFCS PEARLS™ (SAT2) Filter sheet small multifilament
• 08720387388066 - AFCS PEARLS™ Filter sheet large monofilament: 2021-08-30 Air-Fluidized bed - see www.synergiecare.com AFCS PEARLS™ (SAT2) Filter sheet large monofilament
• 08720387388073 - AFCS PEARLS™ Filter sheet small monofilament: 2021-08-30 Air-Fluidized bed - see www.synergiecare.com AFCS PEARLS™ (SAT2) Filter sheet small monofilament