AccessGUDID - DEVICE: Stand Assist Electric Lifter (00616784070216)

GUDID

Device Identifier (DI) Information

Brand Name: Stand Assist Electric Lifter
Version or Model: 10702
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Dynarex Corporation

Primary DI Number: 00616784070216
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 008124539 *Terms of Use

Device Description: No description.

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?
37937	Standing transfer platform, electric	An electrically-powered device designed to assist a healthcare provider in the physical moving (transfer) of a patient with a disability in an upright (standing) position over a short distance on a horizontal plane. It consists of a wheeled platform with a low centre of gravity and a surrounding framework with body securing devices (e.g., belts, foot plates, knee pads) to hold the patient being transferred in the standing position, and includes a powered mechanism to, e.g., to adjust the platform to assist standing. It is neither intended to maintain the patient in a prolonged standing position (i.e., not a stander) nor intended to lift and suspend the patient (i.e., not a patient lift).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FNG	Lift, Patient, 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: d7fa0924-ee42-4b8f-8d34-cabbfc4ed60f
Public Version Date: October 09, 2024
Public Version Number: 4
DI Record Publish Date: September 25, 2019

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: Yes
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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