AccessGUDID - DEVICE: ClearLine MD (00863193000338)

GUDID

Device Identifier (DI) Information

Brand Name: ClearLine MD
Version or Model: Part#:2126
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ANESTHESIA SAFETY PRODUCTS, LLC

Primary DI Number: 00863193000338
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 364188032 *Terms of Use

Device Description: ClearLine IV, (the new product name of AirPurge System - Control Unit), is intended for detection and automatic removal of air in intravenous lines during administration of intravenous solutions, blood and blood products. It is indicated for use in the Operating Room and post anesthesia care areas. The ClearLine IV is placed distal to I.V. bags using gravity feed or pressure, and may be used with or without fluid warmer.

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:	No
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?
36437	Haemodialysis system air/foam detector	A mains electricity (AC-powered) device designed to identify air bubbles and/or foam in blood returned to the body [usually through an arteriovenous fistula (AVF)] by the extracorporeal blood circuit of a haemodialysis system. It may detect the air bubbles/foam using either ultrasonic sensors (i.e., detecting changes in acoustic density), or less frequently using photoelectric sensors (e.g., a photocell). If bubbles/foam are detected, the device usually triggers alarms and activates automated mechanisms to stop the infusion.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OKL	Intravascular Administration Set, Automated Air Removal System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN080009	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
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: 2426cd91-c021-45e8-a299-37d8dd98bbc1
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016