COSEAL SPRAY SET 1514243

GUDID 35413765583415

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.

BAXTER HEALTHCARE CORPORATION

Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel
Primary Device ID35413765583415
NIH Device Record Key09639216-c653-41c6-9bc1-08c866ca0d72
Commercial Distribution StatusIn Commercial Distribution
Brand NameCOSEAL SPRAY SET
Version Model Number1514243
Catalog Number1514243
Company DUNS005083209
Company NameBAXTER HEALTHCARE CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(888)229-0001
Emailmedinfo_medproducts@baxter.com
Phone+1(888)229-0001
Emailmedinfo_medproducts@baxter.com
Phone+1(888)229-0001
Emailmedinfo_medproducts@baxter.com
Phone+1(888)229-0001
Emailmedinfo_medproducts@baxter.com
Phone+1(888)229-0001
Emailmedinfo_medproducts@baxter.com
Phone+1(888)229-0001
Emailmedinfo_medproducts@baxter.com
Phone+1(888)229-0001
Emailmedinfo_medproducts@baxter.com
Phone+1(888)229-0001
Emailmedinfo_medproducts@baxter.com
Phone+1(888)229-0001
Emailmedinfo_medproducts@baxter.com
Phone+1(888)229-0001
Emailmedinfo_medproducts@baxter.com
Phone+1(888)229-0001
Emailmedinfo_medproducts@baxter.com
Phone+1(888)229-0001
Emailmedinfo_medproducts@baxter.com
Phone+1(888)229-0001
Emailmedinfo_medproducts@baxter.com
Phone+1(888)229-0001
Emailmedinfo_medproducts@baxter.com
Phone+1(888)229-0001
Emailmedinfo_medproducts@baxter.com
Phone+1(888)229-0001
Emailmedinfo_medproducts@baxter.com
Phone+1(888)229-0001
Emailmedinfo_medproducts@baxter.com
Phone+1(888)229-0001
Emailmedinfo_medproducts@baxter.com
Phone+1(888)229-0001
Emailmedinfo_medproducts@baxter.com
Phone+1(888)229-0001
Emailmedinfo_medproducts@baxter.com
Phone+1(888)229-0001
Emailmedinfo_medproducts@baxter.com
Phone+1(888)229-0001
Emailmedinfo_medproducts@baxter.com
Phone+1(888)229-0001
Emailmedinfo_medproducts@baxter.com
Phone+1(888)229-0001
Emailmedinfo_medproducts@baxter.com
Phone+1(888)229-0001
Emailmedinfo_medproducts@baxter.com
Phone+1(888)229-0001
Emailmedinfo_medproducts@baxter.com
Phone+1(888)229-0001
Emailmedinfo_medproducts@baxter.com
Phone+1(888)229-0001
Emailmedinfo_medproducts@baxter.com
Phone+1(888)229-0001
Emailmedinfo_medproducts@baxter.com
Phone+1(888)229-0001
Emailmedinfo_medproducts@baxter.com
Phone+1(888)229-0001
Emailmedinfo_medproducts@baxter.com
Phone+1(888)229-0001
Emailmedinfo_medproducts@baxter.com
Phone+1(888)229-0001
Emailmedinfo_medproducts@baxter.com
Phone+1(888)229-0001
Emailmedinfo_medproducts@baxter.com
Phone+1(888)229-0001
Emailmedinfo_medproducts@baxter.com
Phone+1(888)229-0001
Emailmedinfo_medproducts@baxter.com
Phone+1(888)229-0001
Emailmedinfo_medproducts@baxter.com
Phone+1(888)229-0001
Emailmedinfo_medproducts@baxter.com
Phone+1(888)229-0001
Emailmedinfo_medproducts@baxter.com
Phone+1(888)229-0001
Emailmedinfo_medproducts@baxter.com
Phone+1(888)229-0001
Emailmedinfo_medproducts@baxter.com
Phone+1(888)229-0001
Emailmedinfo_medproducts@baxter.com
Phone+1(888)229-0001
Emailmedinfo_medproducts@baxter.com
Phone+1(888)229-0001
Emailmedinfo_medproducts@baxter.com
Phone+1(888)229-0001
Emailmedinfo_medproducts@baxter.com
Phone+1(888)229-0001
Emailmedinfo_medproducts@baxter.com
Phone+1(888)229-0001
Emailmedinfo_medproducts@baxter.com
Phone+1(888)229-0001
Emailmedinfo_medproducts@baxter.com
Phone+1(888)229-0001
Emailmedinfo_medproducts@baxter.com
Phone+1(888)229-0001
Emailmedinfo_medproducts@baxter.com
Phone+1(888)229-0001
Emailmedinfo_medproducts@baxter.com
Phone+1(888)229-0001
Emailmedinfo_medproducts@baxter.com
Phone+1(888)229-0001
Emailmedinfo_medproducts@baxter.com
Phone+1(888)229-0001
Emailmedinfo_medproducts@baxter.com
Phone+1(888)229-0001
Emailmedinfo_medproducts@baxter.com
Phone+1(888)229-0001
Emailmedinfo_medproducts@baxter.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS105413765583414 [Primary]
GS135413765583415 [Package]
Contains: 05413765583414
Package: PACK_OR_INNER_PACK [10 Units]
In Commercial Distribution
GS155413765583419 [Package]
Contains: 05413765583414
Package: CASE [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NBESealant, polymerizing

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-08
Device Publish Date2020-09-30

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51978860004367 - CLEARLINK/CONTINU-FLO2024-04-04 QuickStay Set, 24 Hour Max Use, For Gravity Use Only, Clearlink System, Non-DEHP Continu-Flo Solution Set with Duo-Vent Spike, 9
05413765580895 - NOV - Novum IQ2023-11-30 Infusion Pump Management unit, mobile
50085412676635 - DUO - DUO-VENT2023-07-19 Solution Set with DUO-VENT Spike
05413765891335 - PerClot2023-07-03 PerClot 1g - 9cm Standard Tip
05413765891366 - PerClot2023-07-03 PerClot 3g - 9cm Standard Tip
05413765891373 - PerClot2023-07-03 PerClot 5g - 9cm Standard Tip

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