AccessGUDID - DEVICE: ook snow ALL (00670482000142)

GUDID

Device Identifier (DI) Information

Brand Name: ook snow ALL
Version or Model: 200-0000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 200-0000
Company Name: Umano Medical Inc

Primary DI Number: 00670482000142
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 249675476 *Terms of Use

Device Description: AC-powered medical bed with 4 built-in electric DC actuators that offers a powered adjustment of the height and surface contours. Bed includes movable and latchable siderails, and control boards. The patient sleep surface can be manually extended of 4” with the integrated bed length extender and reach 84” or 88” long. The surface width can be manually extended from 35” up to 47”. The product offers a range of options and accessories including but not limited to integrated scale, integrated bed exit system, fixed or foldable IV pole, patient helper, oxygen bottle holder and length extension cushions.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
34870	Basic electric hospital bed	A mains electricity (AC-powered) bed designed to be used as a patient bed for rest/sleep in a hospital ward/room, and which is motorized providing the patient/nursing staff with touch button adjustment possibilities. It typically includes a framework with wheels, a mattress support platform that can articulate, a headboard and footboard, siderails, and a remote control to operate the electrical motors. It may have an integrated weighing scale.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FNL	Bed, Ac-Powered Adjustable Hospital

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: 86c7ed56-07ff-4cd8-8e4f-c3c4cea66721
Public Version Date: September 21, 2018
Public Version Number: 1
DI Record Publish Date: August 21, 2018