AccessGUDID - DEVICE: Handi-Move Sling (05404016613721)

GUDID

Device Identifier (DI) Information

Brand Name: Handi-Move Sling
Version or Model: 3551M 00000001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3551M 00000001
Company Name: Handi-Move

Primary DI Number: 05404016613721
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 283658730 *Terms of Use

Device Description: Sling 3551 M

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?
33476	Patient lifting system divided leg sling	A lifting device used together with a patient lifting system to provide a support for an incapacitated patient or a person with a disability that is being lifted in a sitting position with their legs held apart and posterior exposed for toileting and washing. It is typically designed as a U-shaped sling construction made of strengthened fabric with lifting straps, a back support with or without head support and individual leg straps (bands) that are wrapped around each leg to support the patient/person in a sitting position with divided legs. This is a reusable device.	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: ad010285-d9b0-4b79-b1ec-a01f7226d383
Public Version Date: July 18, 2024
Public Version Number: 1
DI Record Publish Date: July 10, 2024

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: Yes
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: Yes CLOSE

Customer Contact

[?]

Phone: +1(800) 724-5305
Email: info@surehands.com

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