AccessGUDID - DEVICE: K-2oem ALT-AIRE+ (00817012022353)

GUDID

Device Identifier (DI) Information

Brand Name: K-2oem ALT-AIRE+
Version or Model: U-K-2oemXMS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: U-K-2oemXMS
Company Name: KAP MEDICAL

Primary DI Number: 00817012022353
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 135241342 *Terms of Use

Device Description: On-Demand Low Air loss Expandable mattress system, 80"-84"-88" x 36"-42"-48" x 10"

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
FNM	Mattress, Air Flotation, Alternating 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
No Device Sizes

Device Record Status

Public Device Record Key: e4b86134-8177-4e70-b34b-8b04aab0bc0a
Public Version Date: May 23, 2019
Public Version Number: 1
DI Record Publish Date: May 15, 2019