AccessGUDID - DEVICE: K-6oem AIRE-TURN ASSIST (00817012028126)

GUDID

Device Identifier (DI) Information

Brand Name: K-6oem AIRE-TURN ASSIST
Version or Model: K-6oem-UK-CON-B48
Commercial Distribution Status: In Commercial Distribution
Catalog Number: K-6oem-UK-CON-B48
Company Name: KAP MEDICAL

Primary DI Number: 00817012028126
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 135241342 *Terms of Use

Device Description: Powered Convertible, Rotation,Alternating Pressure with On-Demand Low Air Loss 48" Wide Foam-Air Mattress, Bariatric UK System

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?
17593	Low-air-loss bed	A mains electricity (AC-powered) bed that permits a controlled release of air through its dedicated mattress and is used for tissue pressure management during patient confinement in a hospital acute care department and nursing homes. The device consists of a mattress made of a series of connected air inflated pillows upon which the patient lies, a compressor with a feed system, filters and a built-in control unit.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IKZ	Bed, Patient Rotation, Powered

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: 02acd2f2-7450-45d8-a4bb-15527e636814
Public Version Date: July 06, 2020
Public Version Number: 1
DI Record Publish Date: June 26, 2020