AccessGUDID - DEVICE: Vancare Vanturn (00850030758675)

GUDID

Device Identifier (DI) Information

Brand Name: Vancare Vanturn
Version or Model: Vanturn 450
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MFG-4-1-7600
Company Name: VANCARE INC

Primary DI Number: 00850030758675
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 621114982 *Terms of Use

Device Description: Manual transfer aid. Weight capacity 450 lbs. Purple in color.

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?
37953	Standing transfer platform, manual	A manually-operated device designed as a platform for use by healthcare professionals to assist in the physical moving (transfer) of a patient with a disability in an upright (standing) position over a short distance on a horizontal plane. Sometimes referred to as a rota stand it consists of a wheeled platform with a low centre of gravity and a surrounding framework, shinpad and/or handlebar; it may include body securing devices (e.g., belts, foot straps, knee pads) to hold the person being transferred in the standing position. It is neither intended to mechanically assist standing nor facilitate gait.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FSA	Lift, Patient, Non-Ac-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: 6504b956-3600-4c3a-a667-f8bcff8b79fb
Public Version Date: August 05, 2022
Public Version Number: 2
DI Record Publish Date: October 13, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES