AccessGUDID - DEVICE: DRIVEMEDICAL (00822383581163)

GUDID

Device Identifier (DI) Information

Brand Name: DRIVEMEDICAL
Version or Model: DS-13262M
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Drive Devilbiss Healthcare

Primary DI Number: 00822383581163
Issuing Agency: GS1
Commercial Distribution End Date: August 19, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 867673159 *Terms of Use

Device Description: Patient RoomSlings Product Description: DS Divided Leg Sling, Med,1/ea

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: a2d221e0-47ee-4b40-827a-7962f27e9be5
Public Version Date: August 20, 2024
Public Version Number: 2
DI Record Publish Date: June 21, 2019