AccessGUDID - DEVICE: Handicare (00810045513102)

GUDID

Device Identifier (DI) Information

Brand Name: Handicare
Version or Model: 5208H4430-S
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HANDICARE USA, INC.

Primary DI Number: 00810045513102
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 800145836 *Terms of Use

Device Description: Custom Hammock Spacer Sling with THS-Medium

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?
38869	Patient lifting system hammock 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 or semi-recumbent position with their body (back, head, arms, buttocks and upper legs) enveloped within the sling. It is typically designed as a rectangular piece of strengthened fabric with lifting straps or eyes; it may be with or without a commode aperture. This type of sling disperses the body weight over a large area of material reducing the likelihood of pressure sores; no user cooperation is required. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
INE	Sling, Overhead Suspension, Wheelchair

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: 17dfc8ff-932d-48b6-ac19-993fe4246784
Public Version Date: September 16, 2024
Public Version Number: 2
DI Record Publish Date: December 07, 2022

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: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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