AccessGUDID - DEVICE: DIGNITY®POWER INJECTABLE TITANIUM PORT (00884908093513)

GUDID

Device Identifier (DI) Information

Brand Name: DIGNITY®POWER INJECTABLE TITANIUM PORT
Version or Model: MRTTI96801
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Medical Components, Inc.

Primary DI Number: 00884908093513
Issuing Agency: GS1
Commercial Distribution End Date: September 04, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 038000253 *Terms of Use

Device Description: 9.6F TITANIUM DIGNITY® MID-SIZED CT PORTMID-SIZED CT PO W/PRE-ATTACHED SILICONEW/PRE-ATT CATHETERCATHETER

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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:	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?
61494	Vascular port/catheter	A fully-implantable device assembly intended to provide access to arteries/veins (excludes coronary and intracerebral circulation) for infusion (e.g., chemotherapeutic agents, blood transfusions) and/or drainage (e.g., blood). It consists of: 1) a subcutaneous chamber, with a self-sealing puncturable septum for percutaneous insertion of a hypodermic needle; and 2) an attached catheter which passes into the arteries/veins. It may consist of two chambers attached to a dual-lumen catheter for simultaneous infusion. It is made of metal [e.g., titanium (Ti)] and/or synthetic polymers (e.g., silicone); disposable devices associated with implantation may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LJT	PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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
No Device Sizes

Device Record Status

Public Device Record Key: 68912bbf-8829-4e23-8516-36205b807f3d
Public Version Date: October 23, 2019
Public Version Number: 8
DI Record Publish Date: December 19, 2017