AccessGUDID - DEVICE: Single Patient Use HoverMatt (00816299010824)

GUDID

Device Identifier (DI) Information

Brand Name: Single Patient Use HoverMatt
Version or Model: HM34SPU
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HM34SPU
Company Name: Hovertech International

Primary DI Number: 00816299010824
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 942139841 *Terms of Use

Device Description: 34" Single Patient Use HoverMatt

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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":	Yes
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?
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.	Obsolete	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
Storage Environment Temperature: between -40 and 158 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Width: 34 Inch

Device Record Status

Public Device Record Key: fa082fd9-3c3d-46b9-a374-9ababd44533f
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: July 30, 2016