AccessGUDID - DEVICE: ASEPT Peritoneal Drainage System (00813623014220)

GUDID

Device Identifier (DI) Information

Brand Name: ASEPT Peritoneal Drainage System
Version or Model: M7060
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M7060
Company Name: PFM MEDICAL INCORPORATED

Primary DI Number: 00813623014220
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 097736867 *Terms of Use

Device Description: ASEPT Drainage Bag with Procedure Pack

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:	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?
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
FMH	Container, Specimen, Sterile

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K093796	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
No Device Sizes

Device Record Status

Public Device Record Key: 96293d00-2b52-4e1d-bb80-b3b284e4374c
Public Version Date: September 05, 2019
Public Version Number: 4
DI Record Publish Date: October 15, 2015