ClearLine MD

Primary DI
00863193000321
Brand
ClearLine MD
Company
ANESTHESIA SAFETY PRODUCTS, LLC
Model
Part#:2240
Device description
ClearLine MD Disposable Cartridge with Collection Bag (the new product name of AirPurge System - Disposable unit), is a sterile, single use cartridge, shall be used with ClearLine IV.
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
00863193000321PrimaryGS10
00863193000314Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00863193000321008631930003218631930003210863193000321
00863193000314008631930003148631930003140863193000314

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous administration setA collection of noninvasive devices designed to conduct fluids from an intravenous (IV) administration bag/bottle to a peripheral venous cannula (not included) during gravitational or pump administration to a patient's venous system; some types may in addition be intended for enteral feeding applications. It typically includes tubing, connectors, chambers, clamps; the bag/bottle may be included. It does not include devices intended for invasive use nor a heat exchanger. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
364188032
Device count
40
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00863193000338ClearLine MDPart#:21262016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00863193000338ClearLine MDANESTHESIA SAFETY PRODUCTS, LLCOKL2016-09-23