AccessGUDID - DEVICE: AFCS PEARLS™ Control unit (08720387388004)

GUDID

Device Identifier (DI) Information

Brand Name: AFCS PEARLS™ Control unit
Version or Model: SAT2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2010002-US
Company Name: Synergie Nederland B.V.

Primary DI Number: 08720387388004
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 417294923 *Terms of Use

Device Description: Air-Fluidized bed - see www.synergiecare.com AFCS PEARLS™ (SAT2) Innovative care Control Unit

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35921	Air-fluidized bed	A mains electricity (AC-powered) bed designed for the treatment of severely and extensively burned patients. It may also be used in cases of decubitus ulcers or where the patient has little remaining body fat (extreme anorexia) and the displacement of the body weight is vital. It employs the circulation of filtered and temperature-regulated air forced through large quantities of ceramic spherules (small round beads) which become transformed from a solid mass into an almost liquid (fluidized) state, providing the patient with complete uplift over the whole supine body surface. Other beneficial effects are the drying of wound seepage and reduction of infection risk.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
INX	Bed, Air Fluidized

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3df98db1-c1b6-4e62-b19b-1636a11a4d7f
Public Version Date: August 30, 2021
Public Version Number: 1
DI Record Publish Date: August 20, 2021