FDA.reportPublic FDA data

NA

Primary DI
00673978522487
Brand
NA
Company
MEDTRONIC, INC.
Model
BT945
Device description
SPIKE BT945 TRANSFER
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWETUBING, PUMP, CARDIOPULMONARY BYPASS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWETubing, Pump, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K812292000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K812292000AUTOTRANS BT795Electromedics, Inc.1981-10-23CAC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10673978522484PackageGS120In Commercial Distribution
00673978522487PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1067397852248410673978522484
00673978522487006739785224876739785224870673978522487

GMDN Terms#

Term, Definition table
TermDefinition
Autotransfusion system blood component processing setA collection of noninvasive devices that typically includes tubing, containers (e.g., bags or bowls for treatment, reinfusion, waste disposal) and filters intended to be used to process (filter/wash) blood components (e.g., red or white blood cells, platelets) in conjunction with a dedicated pump (not included) as part of an autotransfusion procedure; it is not dedicated to suction and/or anticoagulation. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry place away from extremes of temperature.

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
006261481
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00643169013995NA207211A2017-02-02
00643169014008NA2072112017-02-02
00643169014039NA206211A2017-02-02
00643169014046NA2062112017-02-02
00643169014053NA205211A2017-02-02
00643169014060NA2052112017-02-02
00643169014077INPUT™ TS091102A2017-02-02
00643169014084INPUT™ TS091101A2017-02-03
00643169014091INPUT™ TS090037A2017-02-02
00643169014107INPUT™ PS0900232017-02-02
00643169014121INPUT™ PS8933112017-02-02
00643169014138INPUT™ PS8833112017-02-03
00643169014145INPUT™ PS8733112017-02-03
00643169014152INPUT™ PS8633112017-02-02
00643169014169INPUT™ PS8533112017-02-02
00643169014176NA6933112016-08-20
00643169014213NA6633112017-02-02
00643169014220NA6533112017-02-02
00643169014237INPUT™ PS5933112017-02-03
00643169014244INPUT™ PS5833112017-02-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00803622164965Perfusion PackLIVANOVA USA, INC.DWE2026-10-22
00803622164804Perfusion PackLIVANOVA USA, INC.DWE2026-10-19
00803622164811Perfusion PackLIVANOVA USA, INC.DWE2026-10-19
00803622164842Perfusion PackLIVANOVA USA, INC.DWE2026-10-19
00803622164927Perfusion PackLIVANOVA USA, INC.DWE2026-10-19
00803622164934Perfusion PackLIVANOVA USA, INC.DWE2026-10-19
00803622164941Perfusion PackLIVANOVA USA, INC.DWE2026-10-19
00803622164958Perfusion PackLIVANOVA USA, INC.DWE2026-10-19
00803622164989Perfusion PackLIVANOVA USA, INC.DWE2026-10-19
00803622164996Perfusion PackLIVANOVA USA, INC.DWE2026-10-19
00803622165047Perfusion PackLIVANOVA USA, INC.DWE2026-10-19
00803622165054Perfusion PackLIVANOVA USA, INC.DWE2026-10-19
00803622164774Perfusion PackLIVANOVA USA, INC.DWE2026-10-06
00803622164781Perfusion PackLIVANOVA USA, INC.DWE2026-10-06
00803622164798Perfusion PackLIVANOVA USA, INC.DWE2026-10-06
00803622164866Perfusion PackLIVANOVA USA, INC.DWE2026-10-06
00803622164873Perfusion PackLIVANOVA USA, INC.DWE2026-10-06
00803622164880Perfusion PackLIVANOVA USA, INC.DWE2026-10-06
00803622164897Perfusion PackLIVANOVA USA, INC.DWE2026-10-06
00803622164903Perfusion PackLIVANOVA USA, INC.DWE2026-10-06
00803622164736Perfusion PackLIVANOVA USA, INC.DWE2026-09-29
00803622164743Perfusion PackLIVANOVA USA, INC.DWE2026-09-29
00803622164651Perfusion PackLIVANOVA USA, INC.DWE2026-09-28
00803622164675Perfusion PackLIVANOVA USA, INC.DWE2026-09-28
00803622164682Perfusion PackLIVANOVA USA, INC.DWE2026-09-28
00803622164705Perfusion PackLIVANOVA USA, INC.DWE2026-09-28
00803622164712Perfusion PackLIVANOVA USA, INC.DWE2026-09-28
00803622164729Perfusion PackLIVANOVA USA, INC.DWE2026-09-28
00803622164767Perfusion PackLIVANOVA USA, INC.DWE2026-09-28
00803622164477Perfusion PackLIVANOVA USA, INC.DWE2026-09-22