FDA.reportPublic FDA data

COSEAL SPRAY SET

Primary DI
05413765583414
Brand
COSEAL SPRAY SET
Company
BAXTER HEALTHCARE CORPORATION
Model
1514243
Catalog number
1514243
Device description
Spray set consisting of: 2 Spray Heads 1 dual-lumen connection tube consisting of a pressure line with a transparent sterile filter, and a thinner sensing line with a blue sterile filter and an EASYSPRAY-Clip to be attached to the COSEAL Surgical Sealant plunger for gas activation.
Published
2020-09-30
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
NBESealant, polymerizing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBESealant, PolymerizingUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P030039024

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P030039024COSEAL SURGICAL SEALANTBaxter Bio Science2003-12-12NBE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
35413765583415PackageGS110In Commercial Distribution
55413765583419PackageGS13In Commercial Distribution
05413765583414PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3541376558341535413765583415
5541376558341955413765583419
05413765583414054137655834145413765583414

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery adhesive/sealant applicator, dual-channelA sterile dual-channel delivery device designed to enable a surgeon to apply with precision a two-component medication or adhesive/sealant to a surgical site during open surgery (e.g., arterial anastomosis, colonic anastomosis, and vascular graft reconstruction). The device, also known as a surgical sealant dispenser (SSD), is typically made of flexible metal or synthetic material, and has a connector at one end to attach a compatible dispensing device (e.g., a dual-component syringe). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature36 Degrees Fahrenheit86 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+1(888)229-0001medinfo_medproducts@baxter.com

Regulatory Flags#

DUNS number
005083209
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00085412003252Aviva/Viaflex2B80662B80662016-09-24
00085412036311Baxter2C62502C62502016-09-24
00085412600024DUPLOCATH150616515061652018-09-28
00085412600031DUPLOCATH150616615061662018-09-28
00085412600048DUPLOCATH150616715061672018-09-28
00085412002576INTERLINK2C74512C74512016-09-24
00085412002583INTERLINK/DUO-VENT2C74522C74522016-09-24
00085412004976INTERLINK2N33952N33952016-09-24
00085412046334CLEARLINK2C86712C86712016-09-24
00085412046433CLEARLINK2H86032H86032016-09-24
00085412048963CLEARLINK2C86102C86102016-09-24
00085412049007CLEARLINK2C86322C86322016-09-24
00085412049014CLEARLINK2C86062C86062016-09-24
00085412051727CLEARLINK1C86931C86932016-09-24
00085412070056CLEARLINK2C86122C86122016-09-24
00085412071671CLEARLINK2C86072C86072016-09-24
00085412071718CLEARLINK2C89212C89212016-09-24
00085412080949CLEARLINK2H86312H86312016-09-24
00085412080956CLEARLINK2H86712H86712016-09-24
00085412000046INTRAVIA2B80142B80142016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05413765583520PREVELEAK SURGICAL SEALANTBaxter Healthcare CorporationNBE2022-02-22
05413765583582PREVELEAK SURGICAL SEALANTBaxter Healthcare CorporationNBE2022-02-22
25413765583524PREVELEAK SURGICAL SEALANTBaxter Healthcare CorporationNBE2022-02-22
25413765583586PREVELEAK SURGICAL SEALANTBaxter Healthcare CorporationNBE2022-02-22
05413765583599PREVELEAK SURGICAL SEALANTBaxter Healthcare CorporationNBE2021-06-01
05413765583605PREVELEAK SURGICAL SEALANTBaxter Healthcare CorporationNBE2021-06-01
25413765583593PREVELEAK SURGICAL SEALANTBaxter Healthcare CorporationNBE2021-06-01
25413765583609PREVELEAK SURGICAL SEALANTBaxter Healthcare CorporationNBE2021-06-01
35413765583415COSEAL SPRAY SETBAXTER HEALTHCARE CORPORATIONNBE2020-09-30
10801741099370TridyneNEOMEND, INC.NBE2018-10-31
00801741099366TridyneNEOMEND, INC.NBE2018-10-31
00801741099380TridyneNEOMEND, INC.NBE2018-10-31
20801741099377Tridyne™ Vascular Sealant Standard Spray TipsNEOMEND, INC.NBE2018-10-31
10801741099363Tridyne™ Vascular SealantNEOMEND, INC.NBE2018-10-31
10801741099387Tridyne™ Vascular Sealant Extended Spray TipsNEOMEND, INC.NBE2018-10-31
00085412083322Coseal Surgical Sealant Replacement ApplicatorBAXTER HEALTHCARE CORPORATIONNBE2017-10-09
50085412083327Coseal Surgical Sealant Replacement ApplicatorBAXTER HEALTHCARE CORPORATIONNBE2017-10-09
00085412083339Coseal Surgical Sealant Extended ApplicatorBAXTER HEALTHCARE CORPORATIONNBE2017-10-09
00085412087788Coseal Spray SetBaxter Healthcare SANBE2017-03-23
00850868002049PreveLeak™ Surgical SealantTenaxis Medical, Inc.NBE2015-12-31
00850868002056PreveLeak™ 10 pack TipsTenaxis Medical, Inc.NBE2015-12-31
05413765404627Coseal Surgical SealantBAXTER HEALTHCARE CORPORATIONNBE2015-06-10
05413765404634Coseal Surgical SealantBAXTER HEALTHCARE CORPORATIONNBE2015-05-05
05413765404610Coseal Surgical SealantBAXTER HEALTHCARE CORPORATIONNBE2015-05-04
10705031133105ETHICON OMNEXEthicon Inc.NBE2014-09-20
30705031133109ETHICON OMNEXETHICON INC.NBE2014-09-20
00850868002025PreveLeak™ Surgical SealantTenaxis Medical, Inc.NBE2014-09-15
00850868002032PreveLeak™ Surgical SealantTenaxis Medical, Inc.NBE2014-09-15
00850868002063PreveLeak™ Surgical SealantTenaxis Medical, Inc.NBE2014-09-15
10801741010030ProgelNEOMEND, INC.NBE2014-09-12