AccessGUDID - DEVICE: DRIVEMEDICAL (00779709010206)

GUDID

Device Identifier (DI) Information

Brand Name: DRIVEMEDICAL
Version or Model: RTL1020
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Drive Devilbiss Healthcare

Primary DI Number: 00779709010206
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: Long Bath Sponge,24" Offset,1EA,12/CS

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?
40880	Assistive bathing sponge	A device designed to be used by a person with a disability to assist them in attending to their personal body washing needs. It is a bathing sponge made of natural sponge material or synthetic material that will have a purpose-made handle or grip to facilitate its use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ILD	ADAPTOR, DRESSING

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: eb91f8fe-569f-403b-8841-ca5fc795ca4d
Public Version Date: July 15, 2019
Public Version Number: 3
DI Record Publish Date: July 10, 2017