FDA.reportPublic FDA data

NA

Primary DI
10673978522484
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
Rx
false
OTC
false
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
Blood-processing autotransfusion system setA collection of devices designed to handle blood in the washing procedure performed by a blood-processing autotransfusion unit. The collection typically includes plastic tubing, filters (e.g., bacteria), connectors, and bags (e.g., red blood cell, waste); it may also include a disposable bowl for the processing solution (e.g., saline). The set is used as a disposable component of the autotransfusion system during surgery and/or treatment of trauma to remove waste and improve the safety of autologous reinfused blood (autotransfusion). 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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
006261481
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

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00763000368470Aurora EV-ICD™ MRI SureScan™DVEA3E42023-11-02
00763000001513Primo MRI™ DR SureScan™DDMD3D42018-06-02
00763000001551Primo MRI™ VR SureScan™DVMD3D42018-06-02
00763000059491Evera MRI™ XT DR SureScan®DDMB1D42017-10-20
00763000059651Viva™ Quad XT CRT-DDTBA1QQ2017-10-21
00763000059668Viva™ XT CRT-DDTBA1D42017-10-21
00763000059705Evera MRI™ S DR SureScan®DDMC3D42017-10-21
00643169314092Evera MRI™ XT DR SureScan®DDMB1D42015-09-21
00643169314153Evera MRI™ XT VR SureScan®DVMB1D42015-09-21
00643169720497Evera MRI™ XT DR SureScan®DDMB1D42017-09-15
00643169735637Percepta™ CRT-P MRI SureScan™W1TR012017-06-18
00643169735644Percepta™ Quad CRT-P MRI SureScan™W4TR012017-06-18
00643169735651Serena™ CRT-P MRI SureScan™W1TR022017-06-18
00643169735668Serena™ Quad CRT-P MRI SureScan™W4TR022017-06-18
00643169735675Solara™ CRT-P MRI SureScan™W1TR032017-06-18
00643169891401Percepta™ CRT-P MRI SureScan™W1TR012017-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00803622164477Perfusion PackLIVANOVA USA, INC.DWE2026-09-22
00803622164514Perfusion PackLIVANOVA USA, INC.DWE2026-09-22
00803622164569Perfusion PackLIVANOVA USA, INC.DWE2026-09-22
00803622164576Perfusion PackLIVANOVA USA, INC.DWE2026-09-22
00803622164583Perfusion PackLIVANOVA USA, INC.DWE2026-09-22
00803622164590Perfusion PackLIVANOVA USA, INC.DWE2026-09-22
00803622164606Perfusion PackLIVANOVA USA, INC.DWE2026-09-22
00803622164613Perfusion PackLIVANOVA USA, INC.DWE2026-09-22
00803622164668Perfusion PackLIVANOVA USA, INC.DWE2026-09-22
00803622164699Perfusion PackLIVANOVA USA, INC.DWE2026-09-22
00803622164750Perfusion PackLIVANOVA USA, INC.DWE2026-09-22
00803622164286Perfusion PackLIVANOVA USA, INC.DWE2026-08-25
00803622164316Perfusion PackLIVANOVA USA, INC.DWE2026-08-25
00803622164323Perfusion PackLIVANOVA USA, INC.DWE2026-08-25
00803622164040Perfusion PackLIVANOVA USA, INC.DWE2026-07-30
00803622164071Perfusion PackLIVANOVA USA, INC.DWE2026-07-17
00803622164118Perfusion PackLIVANOVA USA, INC.DWE2026-07-17
00803622164019Perfusion PackLIVANOVA USA, INC.DWE2026-06-26
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