AccessGUDID - DEVICE: Drive (00822383102993)

GUDID

Device Identifier (DI) Information

Brand Name: Drive
Version or Model: 13005
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Drive Devilbiss Healthcare

Primary DI Number: 00822383102993
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 867673159 *Terms of Use

Device Description: Personal CareAids to Daily Living Product Description: Overdoor Exerc.Pulley,1/bx, RTL

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?
11090	Cubicle curtain, reusable	A hanging screen designed to separate a room or a part of a room or cubicle to provide temporary privacy for the occupant. It is used around a bed, in front of a cubicle, or in front of a window. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ION	EXERCISER, NON-MEASURING

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: 8a3bb413-0e7b-4936-bc78-70a9763dcf54
Public Version Date: July 03, 2019
Public Version Number: 1
DI Record Publish Date: June 25, 2019