Floseal 1505291

GUDID 50085412532863

FLOSEAL Hemostatic Matrix, 10 mL

BAXTER HEALTHCARE CORPORATION

Collagen haemostatic agent
Primary Device ID50085412532863
NIH Device Record Key6547cd71-1fd2-49a3-a275-cc0451fe8ff0
Commercial Distribution StatusIn Commercial Distribution
Brand NameFloseal
Version Model Number1505291
Catalog Number1505291
Company DUNS628013963
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 Producttrue
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com

Device Dimensions

Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100085412532868 [Primary]
GS150085412532863 [Package]
Contains: 00085412532868
Package: CASE [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PMXAbsorbable collagen hemostatic agent with thrombin

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-04-12

On-Brand Devices [Floseal]

50085412532863FLOSEAL Hemostatic Matrix, 10 mL
50085412532733FLOSEAL Hemostatic Matrix, 5 mL

Trademark Results [Floseal]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FLOSEAL
FLOSEAL
75355764 2296613 Live/Registered
Baxter International Inc.
1997-09-10

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.