AccessGUDID - DEVICE: Mölnlycke®Z-Flo™ Fluidized Positioner (07323190276325)

GUDID

Device Identifier (DI) Information

Brand Name: Mölnlycke®Z-Flo™ Fluidized Positioner
Version or Model: 1400304
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Mölnlycke Health Care AB

Primary DI Number: 07323190276325
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 631770658 *Terms of Use

Device Description: Ped Medium 2 Positioners Kit with Cover 16x24 and 7x10

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?
62292	Freestanding patient positioner, single-use	A preformed patient-contact device (e.g., cushion, pad, bolster, wedge, elevation pillow) designed to be placed freely on a flat surface (e.g., operating table, stretcher) to position and stabilize a patient or body part typically in preparation for and during various medical procedures [e.g., to align the head, neck and thorax to optimise laryngoscopy in anaesthesia]; it is not attached to a parent device. It is made of shock-absorbing materials (e.g., memory foam) to reduce pressure on the bony prominences of a body part (e.g., torso, arm, leg), and some types are inflatable to provide variable support (e.g., to level the spine in a lateral position). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMP	Protector, skin pressure

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
Device Size Text, specify: 41 x 61 cm / 16 x 24 in and 18 x 25 cm / 7 x 10 in

Device Record Status

Public Device Record Key: d06a332c-43d0-404b-ad39-46cf83399b31
Public Version Date: November 23, 2022
Public Version Number: 2
DI Record Publish Date: October 21, 2022