AccessGUDID - DEVICE: TidalPort Vascular Access Port (M991SP11222K1)

GUDID

Device Identifier (DI) Information

Brand Name: TidalPort Vascular Access Port
Version or Model: TidalPort
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SP11222K
Company Name: NORFOLK MEDICAL

Primary DI Number: M991SP11222K1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 013861471 *Terms of Use

Device Description: Pediatric Titanium TidalPort Vascular Access Port with 5F detached Polyurethane Catheter and Standard Introducer Kit

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?
35911	Infusion/injection port, implantable	A sterile metallic and/or non-metallic device intended to be implanted subcutaneously in a patient for the short- or long-term delivery of fluids or medications to the vascular system or other anatomical region. The device consists of a housing with a self-sealing septum and a catheter connection mechanism. The device may be implanted in various anatomical locations. This is a single-use device.	Obsolete	false

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: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 0.183 Milliliter

Device Record Status

Public Device Record Key: f0b758cd-5181-4580-a112-794bba58f5cc
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 01, 2015