AccessGUDID - DEVICE: Axiom® Mills Sump Atraum™ With ClotStop® (M665111169AT0)

GUDID

Device Identifier (DI) Information

Brand Name: Axiom® Mills Sump Atraum™ With ClotStop®
Version or Model: 111169AT
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: AXIOM MEDICAL, INCORPORATED

Primary DI Number: M665111169AT0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 094439676 *Terms of Use

Device Description: Dual Lumen, Mediastinal, Round, Silicone, Open Tip, With ClotStop®

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":	No
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?
15270	Sump drain	A sterile, tube-like device that has a double lumen which is designed to establish a channel for the removal of fluids from a cavity by allowing air to enter the cavity through the smaller lumen which displaces fluid into the larger lumen. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GBS	Catheter, Ventricular, General & Plastic Surgery

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K883887	000

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
Catheter Gauge: 28 French

Device Record Status

Public Device Record Key: 897e3848-fdd6-4f20-be71-e3b5a6176424
Public Version Date: October 24, 2018
Public Version Number: 1
DI Record Publish Date: September 23, 2018