ClearLine MD

Primary DI
00863193000338
Brand
ClearLine MD
Company
ANESTHESIA SAFETY PRODUCTS, LLC
Model
Part#:2126
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.
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OKLIntravascular Administration Set, Automated Air Removal System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OKLIntravascular Administration Set, Automated Air Removal SystemGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN080009000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN080009000AIRPURGEAnesthesia Safety Products, LLC2014-03-04OKL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00863193000338PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00863193000338008631930003388631930003380863193000338

GMDN Terms#

Term, Definition table
TermDefinition
Haemodialysis system air/foam detectorA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
364188032
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00863193000321ClearLine MDPart#:22402016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00863193000321ClearLine MDANESTHESIA SAFETY PRODUCTS, LLCOKL2016-09-23