AccessGUDID - DEVICE: Pressure Monitoring Lines (00886333201297)

GUDID

Device Identifier (DI) Information

Brand Name: Pressure Monitoring Lines
Version or Model: 040504005A
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 040504005A
Company Name: ARGON MEDICAL DEVICES, INC.

Primary DI Number: 00886333201297
Issuing Agency: GS1
Commercial Distribution End Date: January 29, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 140727624 *Terms of Use

Device Description: Pressure Monitoring Lines Blue 48" Injection Line w/Male & Female Luer Lock Connectors

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?
61836	Cardiopulmonary bypass system pressure-monitoring tubing	A sterile length of flexible tube intended to interface a pressure monitor/manometer with a cardiopulmonary bypass system to allow fluid pressure to be measured; connectors are typically included. 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: 48" Injection Line

Device Record Status

Public Device Record Key: a6dfe541-8856-4903-bdb1-821095ba2562
Public Version Date: January 30, 2024
Public Version Number: 4
DI Record Publish Date: September 12, 2016