Mölnlycke®Z-Flo™ Fluidized Positioner

Basic Information

• Brand Name: Mölnlycke®Z-Flo™ Fluidized Positioner
• Primary DI: 07323190276264
• Version / Model: 1400236
• Company Name: Mölnlycke Health Care AB
• Labeler DUNS: 631770658
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-21
• Public Version: 2
• Public Version Date: 2022-11-23
• Public Version Status: Update
• Public Device Record Key: 553db54f-8c46-440c-875a-ebd6b0e024e5

Device Description

Ped Infant Neck Roll Positioner 7.5x12

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FMP	Protector, skin pressure	General Hospital	880.6450	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	07323190270545	GS1	CASE	12	In Commercial Distribution
Primary	07323190276264	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			19 x 30 cm / 7.5 x 12 in