AccessGUDID - DEVICE: Grafco (M3683953121)

GUDID

Device Identifier (DI) Information

Brand Name: Grafco
Version or Model: 3953 1/2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3953 1/2
Company Name: GF HEALTH PRODUCTS, INC.

Primary DI Number: M3683953121
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 132016168 *Terms of Use

Device Description: TUBING PENROSE DRAIN 1/2

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):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
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?
61520	Peritoneal drainage catheter	A sterile flexible tube designed for percutaneous insertion into the peritoneal space typically to drain ascites and abdominal abscesses. It may include disposable devices dedicated to catheter introduction, however it does not include any fluid collection bags/containers. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GBW	Catheter, Peritoneal

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: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Catheter Inner Diameter: .5 Inch

Device Record Status

Public Device Record Key: 37871cda-dab2-40af-a741-810424816a35
Public Version Date: May 18, 2021
Public Version Number: 1
DI Record Publish Date: May 10, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: M3683953120 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: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 770-368-4700
Email: cs@grahamfield.com

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