AccessGUDID - DEVICE: DryDoc Vacuum Station (00801741151781)

GUDID

Device Identifier (DI) Information

Brand Name: DryDoc Vacuum Station
Version or Model: DD15
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: DD15
Company Name: C. R. Bard, Inc.

Primary DI Number: 00801741151781
Issuing Agency: GS1
Commercial Distribution End Date: August 31, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 016898496 *Terms of Use

Device Description: DryDoc Vacuum Station for Use with PureWick Female External Catheter

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:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	Yes
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?
60917	Bed incontinence system	An assembly of devices intended to be fitted to a home bed and used by an incontinent/bed-bound patient for the removal of excrement and subsequent washing during bed occupancy. It includes a mains electricity (AC-powered) air/water pumping unit with heated water reservoir; waste container; and controls connected via relevant tubing to a suction cup, which conforms to the patientâ€™s perineum. It may also include a bed washing/suction hose for general body cleaning, and a shaped mattress to accommodate the system tubing. Waste (i.e., faeces, urine, and waste water) is intended to be removed through suction; a supply of water and air is used to clean and dry the patient after waste removal.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NZU	Collector, urine, powered, non indwelling catheter

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: 621d9209-d83d-4656-9624-d9ad76f7db7a
Public Version Date: September 04, 2020
Public Version Number: 2
DI Record Publish Date: August 06, 2020