AccessGUDID - DEVICE: AFCS PEARLS™ Filter sheet large monofilament (08720387388066)

GUDID

Device Identifier (DI) Information

Brand Name: AFCS PEARLS™ Filter sheet large monofilament
Version or Model: SAT2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2010605
Company Name: Synergie Nederland B.V.

Primary DI Number: 08720387388066
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) Filter sheet large monofilament

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?
47455	Basic bed sheet, reusable	A large piece of fabric material intended to cover the mattress of a bed to protect it from being soiled and to provide the bed's occupant with clean, non-irritating contact surfaces (over and under); it does not include antimicrobial or nonadherent properties. It is typically made of a thin-textile or reinforced-paper material and is laundered for cleaning between periods of use. This is a reusable device.	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: 350ed8f6-d8d9-4e0a-ba60-7b832e119d31
Public Version Date: August 30, 2021
Public Version Number: 1
DI Record Publish Date: August 20, 2021