AccessGUDID - DEVICE: ACCEL Centesis Catheter (00813623011458)

GUDID

Device Identifier (DI) Information

Brand Name: ACCEL Centesis Catheter
Version or Model: 613214
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 613214
Company Name: PFM MEDICAL INCORPORATED

Primary DI Number: 00813623011458
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 097736867 *Terms of Use

Device Description: 5F x 15cm ACCEL Centesis Catheter Percutaneous Fluid Drainage

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?
40601	Peripheral vascular catheter	A sterile, thin, flexible tube intended to be inserted into the peripheral vasculature of a patient to enable short-term (< 30 days) intravascular access; it is not intended to be advanced to the central vasculature. It typically includes dedicated accessories to facilitate catheter introduction/placement and function (e.g., connectors, injection ports, stylet and/or wings for fixation). It may be used for blood sampling, monitoring of blood pressure, to administer fluids, medication and/or for the injection of contrast media. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
GCB	Needle, Catheter

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
No Device Sizes

Device Record Status

Public Device Record Key: 02e545e3-a81d-4341-a1f2-d4614f2a7d6e
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 29, 2016