AccessGUDID - DEVICE: HoverTech (10817357022381)

GUDID

Device Identifier (DI) Information

Brand Name: HoverTech
Version or Model: HM39SPU-HLF-B
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: HYGIA HEALTH SERVICES, INC.

Primary DI Number: 10817357022381
Issuing Agency: GS1
Commercial Distribution End Date: July 10, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 177939027 *Terms of Use

Device Description: HoverTech HoverMatt Half-Matt 39 in W x 46 in L

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:	Yes
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?
37160	Patient transfer system, powered	A mains electricity (AC-powered) assembly of devices used to transfer a supine patient, typically from his/her bed or transport stretcher to an operating table or vice versa. It is usually installed in large operating room (OR) complexes and serves as a sluice providing demarkation between the OR staff and the ward staff/porters and related devices. It may be designed as a motorized belt that is wider than the length of the patient and that rotates around a moveable pick-up plate which feeds in under the patient, drawing him/her onto the belt and depositing him/her onto an adjacent surface. It is typically fully automated, requiring no human intervention other than to operate the controls.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRZ	Device, Patient Transfer, 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: 2859af88-d1ec-42ce-9c97-8e9b5fc2b45d
Public Version Date: March 19, 2021
Public Version Number: 3
DI Record Publish Date: January 08, 2018