AccessGUDID - DEVICE: ResQUp (00860003643105)

GUDID

Device Identifier (DI) Information

Brand Name: ResQUp
Version or Model: Midnight
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Safe Patient Solutions, L.L.C.

Primary DI Number: 00860003643105
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 017840548 *Terms of Use

Device Description: Self-Recovery device to assist a fallen person moving themselves to a seated position after a non-injurious fall. Color: Midnight

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):	Yes
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?
45678	Mobile patient lifting system, manual	A non-powered, mobile assembly of devices designed to enable one person to lift and move an incapacitated patient or a person with a disability safely and with minimal physical effort. Also known as a patient hoist, it typically consists of a support base on wheels with a lifting mechanism, mast, boom, swivel bar, and patient holding device (e.g., a sling, holder or a frame). The lifting mechanism provides mechanical advantage (e.g., using pneumatic springs) to aid manual movement of components. It is typically used to lift and move the occupant in a sitting or semi-sitting position over short distances within the treatment facility, e.g., from a bed to a bathroom.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IKX	Aid, Transfer

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: c5f597de-299b-4a25-a7bd-9207f8e5fbd4
Public Version Date: December 17, 2021
Public Version Number: 1
DI Record Publish Date: December 09, 2021