AccessGUDID - DEVICE: Drain Connector Tubing (00801741049217)

GUDID

Device Identifier (DI) Information

Brand Name: Drain Connector Tubing
Version or Model: 0034800
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0034800
Company Name: C. R. Bard, Inc.

Primary DI Number: 00801741049217
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 016898496 *Terms of Use

Device Description: ReliaVac PVC Drain Connector Tubing, Medium 10 Fr. (3.2mm, 1/8") Y-Connector

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?
64512	Closed-wound drain connection tubing set	A device collection which includes flexible, noninvasive tubing (typically single or Y-shaped) and associated items (typically connectors, clamps, one-way valve and/or filter) intended to provide a connection between a surgical drain(s)/catheter(s) and a wound drainage container and/or suction source (the catheter, container and suction source are not included) to drain a closed wound. It is not intended to connect components of a surgical suction system (i.e., not used during general surgery). 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
Catheter Gauge: 10 French

Device Record Status

Public Device Record Key: bdfc663b-682f-4254-9f0e-7787f808a51d
Public Version Date: July 31, 2023
Public Version Number: 2
DI Record Publish Date: September 22, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20801741049211	14	10801741049214		In Commercial Distribution	CA
10801741049214	10	00801741049217		In Commercial Distribution	CA

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)526-4455
Email: medical.services@crbard.com

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