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
00199150083855NABB10L80R82026-06-08
00199150083992NABB8B99R92026-06-08
00199150084180NA1D92R42026-06-08
00824846000020NABB12W54R22026-06-08
00824846000983NABB12W65R2026-06-08
00824846001027NABB12C06R52026-06-08
00824846001041NABB12W64R2026-06-08
00824846001065NABB12V57R2026-06-08
00643169530102ATTAIN CLARITY™62252016-07-16
00613994746610ATTAIN SELECT™ II6248130D022016-07-16
00613994746801ATTAIN SELECT™ II6248DEL90DS022016-04-11
20763000946979DLP®872202024-08-15
00199150078455NA11N40R12026-04-26
20643169454594DLP®303172016-09-09
00199150083077NA12V42R2026-05-30
00199150083121NABB1119R72026-05-30
00199150083381NABB12M28R122026-05-30
00199150083442NABB5G97R132026-05-30
00199150083534NABB10U10R172026-05-30
00199150083718NABB6Z03R102026-05-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
H965252810AngioVacNAVILYST MEDICAL, INC.DWE2020-05-11
0061625802153948” (122 cm) High Pressure Connector TubeBAYER MEDICAL CARE INC.DWE2019-10-25
0061625800850948” (122 cm) High Pressure Connector TubeBAYER MEDICAL CARE INC.DWE2016-12-05
0061625800851630” (76 cm) High Pressure Connector TubeBAYER MEDICAL CARE INC.DWE2016-12-05
0061625800852320” (50 cm) High Pressure Connector TubeBAYER MEDICAL CARE INC.DWE2016-12-05
0061625800853010” (25 cm) High Pressure Connector TubeBAYER MEDICAL CARE INC.DWE2016-12-05
00643169137653NAMEDTRONIC, INC.DWE2016-07-23
00613994352811Intersept®MEDTRONIC, INC.DWE2016-06-17
00643169169593NAMEDTRONIC, INC.DWE2016-06-11
00643169229136NAMEDTRONIC, INC.DWE2016-06-11
00643169019287INTERSEPT®MEDTRONIC, INC.DWE2016-06-06
00643169029293NAMEDTRONIC, INC.DWE2016-06-06
00613994363220Intersept®MEDTRONIC, INC.DWE2016-05-28
00613994363237Intersept®MEDTRONIC, INC.DWE2016-05-28
00613994407351INTERSEPT®MEDTRONIC, INC.DWE2016-05-28
00613994407481Intersept®MEDTRONIC, INC.DWE2016-05-28
00613994408426INTERSEPT®MEDTRONIC, INC.DWE2016-05-28
00613994408488Intersept®MEDTRONIC, INC.DWE2016-05-28
00613994462831INTERSEPT®MEDTRONIC, INC.DWE2016-05-28
00613994463494INTERSEPT®MEDTRONIC, INC.DWE2016-05-28
00613994851420INTERSEPT®MEDTRONIC, INC.DWE2016-05-28
00613994897114INTERSEPT®MEDTRONIC, INC.DWE2016-05-28
00613994946317Intersept®MEDTRONIC, INC.DWE2016-05-28
00613994946331Intersept®MEDTRONIC, INC.DWE2016-05-28
00643169021358INTERSEPT®MEDTRONIC, INC.DWE2016-05-28
00643169029125INTERSEPT®MEDTRONIC, INC.DWE2016-05-28
00643169061866INTERSEPT®MEDTRONIC, INC.DWE2016-05-28
00643169096837INTERSEPT®MEDTRONIC, INC.DWE2016-05-28
00643169096905INTERSEPT®MEDTRONIC, INC.DWE2016-05-28
00613994097408NAMEDTRONIC, INC.DWE2016-05-22