FDA.reportPublic FDA data

Drain Line

Primary DI
10803622132138
Brand
Drain Line
Company
LIVANOVA USA, INC.
Model
Drain Line
Published
2016-06-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
CACAPPARATUS, AUTOTRANSFUSION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CACApparatus, AutotransfusionAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K912019000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K912019000ORTHOFUSER WOUND DRAINAGE/AUTOTRANSFUSION SYSTEMGish Biomedical, Inc.1991-10-08CAC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10803622132138PackageGS112In Commercial Distribution
00803622132131PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080362213213810803622132138
00803622132131008036221321318036221321310803622132131

GMDN Terms#

Term, Definition table
TermDefinition
Blood-processing autotransfusion system setA collection of devices designed to handle blood in the washing procedure performed by a blood-processing autotransfusion unit. The collection typically includes plastic tubing, filters (e.g., bacteria), connectors, and bags (e.g., red blood cell, waste); it may also include a disposable bowl for the processing solution (e.g., saline). The set is used as a disposable component of the autotransfusion system during surgery and/or treatment of trauma to remove waste and improve the safety of autologous reinfused blood (autotransfusion). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080914995
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00803622163982Perfusion PackPerfusion Pack2026-07-17
00803622164071Perfusion PackPerfusion Pack2026-07-17
00803622164118Perfusion PackPerfusion Pack2026-07-17
00803622163623Perfusion PackPerfusion Pack2026-07-10
00803622163906Perfusion PackPerfusion Pack2026-07-10
00803622163975Perfusion PackPerfusion Pack2026-07-10
00803622163999Perfusion PackPerfusion Pack2026-07-10
00803622164002Perfusion PackPerfusion Pack2026-07-10
00803622119484Cardioplegia PackCardioplegia Pack2015-04-22
00803622163524Perfusion PackPerfusion Pack2026-07-08
00803622120138Perfusion PackPerfusion Pack2015-04-22
00803622163937Perfusion PackPerfusion Pack2026-06-26
00803622164019Perfusion PackPerfusion Pack2026-06-26
05425025750870VNS Therapy™ Programmer, Model 3100 v2.1.031002026-06-24
00803622163715Perfusion PackPerfusion Pack2026-06-08
00803622163722Perfusion PackPerfusion Pack2026-06-08
00803622163586Perfusion PackPerfusion Pack2026-05-27
00803622163593Perfusion PackPerfusion Pack2026-05-27
00803622163616Perfusion PackPerfusion Pack2026-05-27
00803622163654Perfusion PackPerfusion Pack2026-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14026704937230PLEUR-EVACTELEFLEX INCORPORATEDCAC2026-05-08
14026704937308PLEUR-EVACTELEFLEX INCORPORATEDCAC2026-05-08
14026704937315PLEUR-EVACTELEFLEX INCORPORATEDCAC2026-05-08
14026704912206PLEUR-EVACTELEFLEX INCORPORATEDCAC2025-09-17
14026704912213PLEUR-EVACTELEFLEX INCORPORATEDCAC2025-09-17
14026704911797PLEUR-EVACTELEFLEX INCORPORATEDCAC2025-09-04
14026704911803PLEUR-EVACTELEFLEX INCORPORATEDCAC2025-09-04
14026704911865PLEUR-EVACTELEFLEX INCORPORATEDCAC2025-04-29
08033178113700XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113717XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113724XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113731XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113748XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113755XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113762XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113922XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113939XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113946XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113953XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113960XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113977XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113984XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113991XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178114004XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178114011XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178114028XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178114035XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178114042XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178114059XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178114066XTRASORIN GROUP ITALIA SRLCAC2024-12-20