AccessGUDID - DEVICE: Closed Wound Suction (00801741049613)

GUDID

Device Identifier (DI) Information

Brand Name: Closed Wound Suction
Version or Model: 0070850
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0070850
Company Name: C. R. Bard, Inc.

Primary DI Number: 00801741049613
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 016898496 *Terms of Use

Device Description: ReliaVac 100 Closed Wound Suction Evacuator, Medium Suction 100cc, With 36" (91.4cm) Connector Tubing

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
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?
11301	Closed-wound/centesis drainage receptacle	A sterile container designed to be connected to an invasive drain/drainage catheter (not included) to collect fluids or purulent material being removed during drainage of a body cavity, a closed-wound, and/or the bile duct; it is not intended for drainage of cerebrospinal fluid (CSF) or blood. It is typically in the form of a bottle, bag, or bulb with fluid volume markers, and might include a hand-operated pump (e.g., suction bulb) and tubing; it does not include any invasive components or powered devices. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GCY	APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

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: Yes
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
Total Volume: 100 Milliliter
Length: 36 Inch

Device Record Status

Public Device Record Key: 38ba9d72-d63a-4c71-a301-8d08ba18a67b
Public Version Date: September 30, 2020
Public Version Number: 1
DI Record Publish Date: September 22, 2020