AccessGUDID - DEVICE: Pressure Monitoring Lines Opaque PE Tubing (00886333201242)

GUDID

Device Identifier (DI) Information

Brand Name: Pressure Monitoring Lines Opaque PE Tubing
Version or Model: 040208001A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 040208001A
Company Name: ARGON MEDICAL DEVICES, INC.

Primary DI Number: 00886333201242
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 140727624 *Terms of Use

Device Description: Pressure Monitoring Lines Opaque PE Tubing 8Ft. Line w/Male Luer Lock Connectors on each end

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?
43324	Fluid transfer set, general-purpose	A collection of devices and supplies designed to transfer several types of medical fluids (e.g., drugs, vaccines, blood, and solutions) between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]; it is not dedicated to a particular type of fluid or clinical procedure. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DQO	Catheter, Intravascular, Diagnostic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K781558	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
Device Size Text, specify: 8Ft. Line

Device Record Status

Public Device Record Key: f6fd5eaa-f14a-4886-9e93-792882d38f10
Public Version Date: February 19, 2021
Public Version Number: 4
DI Record Publish Date: September 09, 2016