FDA.reportPublic FDA data

EXTENSION SET

Primary DI
00085412653303
Brand
EXTENSION SET
Company
BAXTER HEALTHCARE CORPORATION
Model
2N3383
Catalog number
2N3383
Device description
Blood Extension Set
Published
2021-12-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BRZSet, blood transfusion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BRZSet, Blood TransfusionGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210335000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210335000Blood Administration SetBaxter Healthcare Corporation2021-06-10BRZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50085412653308PackageGS150In Commercial Distribution
00085412653303PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5008541265330850085412653308
00085412653303000854126533030854126533030085412653303

GMDN Terms#

Term, Definition table
TermDefinition
Blood transfusion set, non-exchangeAn intravascular administration set intended to be used to administer blood from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device typically includes a needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, a stopcock, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an intravenous (IV) bag or other infusion fluid container. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length150Centimeter
Total Volume4.7Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at Room Temperature. Keep away from Direct Sunlight. Keep Dry.

Contacts#

Phone, Email table
PhoneEmail
+1(800)933-0303US-MEDINFO_MEDPRODUCTS@baxter.com

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00085412478296BaxterH93813501H938135012026-05-29
00085412478302BaxterH93813601H938136012026-05-29
00085412004945INTERLINK2N33792N33792016-09-24
00085412004983INTERLINK2N33992N33992016-09-24
00085412048895CLEARLINK2N83992N83992016-09-24
00085412002125INTERLINK2C64022C64022016-09-24
00085412003948INTERLINK/DUO-VENT2C64192C64192016-09-24
00085412017716INTERLINK/CONTINU-FLO3C00623C00622016-09-24
00085412046389CLEARLINK/DUO-VENT2C88752C88752016-09-24
00085412048499CLEARLINK/DUO-VENT2H84802H84802016-09-24
00085412048932CLEARLINK2C84012C84012016-09-24
00085412048949CLEARLINK2C84022C84022016-09-24
00085412048987CLEARLINK/CONTINU-FLO2C85462C85462016-09-24
00085412048994CLEARLINK/CONTINU-FLO2C85192C85192016-09-24
00085412049090CLEARLINK2H84012H84012016-09-24
00085412051703CLEARLINK/CONTINU-FLO2C85152C85152016-09-24
00085412068190INTERLINK2H64012H64012016-09-24
00085412069302CLEARLINK/CONTINU-FLO/CONTROL-A-FLO2C88952C88952016-09-24
00085412071107CLEARLINK/CONTINU-FLO/DUO-VENT2C85412C85412016-09-24
00085412071190CLEARLINK2C84252C84252016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M68980801R120Fresh Whole Blood Recipient SetSafeguard US Operating, LLCBRZ2026-05-04
M68980801R110Fresh Whole Blood Recipient SetSafeguard US Operating, LLCBRZ2025-03-04
M68980875100Low Titer Type O FWB Transfusion SetSafeguard US Operating, LLCBRZ2025-02-09
M68980801R100Fresh Whole Blood Recipient SetSafeguard US Operating, LLCBRZ2024-12-16
M68980875090Low Titer Type O FWB Transfusion SetSafeguard US Operating, LLCBRZ2022-11-04
M68980801R080Fresh Whole Blood Recipient SetSafeguard US Operating, LLCBRZ2022-09-30
M68980801R070Fresh Whole Blood Recipient SetSafeguard US Operating, LLCBRZ2022-09-27
M68980875080Low Titer Type O FWB Transfusion SetSafeguard US Operating, LLCBRZ2022-08-23
50085412653308EXTENSION SETBAXTER HEALTHCARE CORPORATIONBRZ2021-12-23
M68980801R060Fresh Whole Blood Recipient SetSafeguard US Operating, LLCBRZ2021-10-02
M68980875070Low Titer Type O FWB Transfusion SetSafeguard US Operating, LLCBRZ2021-07-28
M68980875030Low Titer Type O FWB Transfusion SetSafeguard US Operating, LLCBRZ2020-03-12
M68980875D030Low Titer Type O Donor Collection SetSafeguard US Operating, LLCBRZ2020-03-12
03660812118484VYGONVYGONBRZ2020-01-29
53660812118489VYGONVYGONBRZ2020-01-29
03660812106122VYGONVYGONBRZ2019-06-26
53660812106127VYGONVYGONBRZ2019-06-26
M69880875020Low Titer Type O FWB Transfusion SetSafeguard US Operating, LLCBRZ2018-09-18
M68980875D020Low Titer Type O Donor Collection SetSafeguard US Operating, LLCBRZ2018-09-18
M68980875010Low Titer Type O FWB Transfusion SetSafeguard US Operating, LLCBRZ2018-05-04
M68980875D010Low Titer Type O Donor Collection SetSafeguard US Operating, LLCBRZ2018-05-04
M68980801R030Fresh Whole Blood Recipient SetSafeguard US Operating, LLCBRZ2018-05-04
04052682004148Fenwal Blood Comp. Recipient Set with Std. Blood Filter with Luer AdapterFresenius Kabi AGBRZ2018-03-26
04052682004193Fenwal Y-Type Blood Comp. Recipient Set with Std. Blood Filter and Luer AdapterFresenius Kabi AGBRZ2018-03-26
14052682004145Fenwal Blood Comp. Recipient Set with Std. Blood FFresenius Kabi AGBRZ2018-03-26
14052682004190Fenwal Y-Type Blood Comp. Recipient Set with Std. Fresenius Kabi AGBRZ2018-03-26
M68980801R020Fresh Whole Blood Recipient SetSafeguard US Operating, LLCBRZ2017-08-04
M68980801R01Fresh Whole Blood Recipient SetSafeguard US Operating, LLCBRZ2017-01-23
00085412002408INTERLINKBAXTER INTERNATIONAL INC.BRZ2016-09-24
00085412004006INTERLINKBAXTER INTERNATIONAL INC.BRZ2016-09-24