AccessGUDID - DEVICE: Drive (00822383271347)

GUDID

Device Identifier (DI) Information

Brand Name: Drive
Version or Model: BL115
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Drive Devilbiss Healthcare

Primary DI Number: 00822383271347
Issuing Agency: GS1
Commercial Distribution End Date: February 14, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 867673159 *Terms of Use

Device Description: Bath SafetyBathing Systems & Lifts Product Description: LAP HARNESS WITH POMMEL,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?
34934	Patient lifting system bath chair	A lifting device designed with a seat, and typically with legs and a back support, used with a patient lifting system to seat, lift, and transfer an incapacitated, geriatric, or disabled patient from a wheelchair into a bath or a tub (prefilled with bathing water or not) and back out again after the bathing session has been completed.	Obsolete	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: a4e495f9-a1f5-42cf-ac0d-7893a601b998
Public Version Date: February 18, 2020
Public Version Number: 1
DI Record Publish Date: February 10, 2020