FDA.reportPublic FDA data

NA

Primary DI
10673978522460
Brand
NA
Company
MEDTRONIC, INC.
Model
BT920
Device description
ADAPTER BT920 CARDIOTOMY TANDEM Y 10PK
Published
2016-09-04
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
K803277000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K803277000TYGON TUBINGElectromedics, Inc.1981-01-13DWE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10673978522460PrimaryGS10
00673978522463Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1067397852246010673978522460
00673978522463006739785224636739785224630673978522463

GMDN Terms#

Term, Definition table
TermDefinition
Red blood cell-recovery 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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
006261481
Device count
10
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150062911N/AAFR-002132026-09-04
00613994733658Pulmonary Wedge Pressure Catheter1500752016-06-12
00613994811639Z2Z26JR4052016-06-11
00613994813053Z2Z26EBU3552016-06-11
00643169356979Z2Z27FR40D2016-04-25
00643169356993Z2Z27AL75D2016-06-11
00643169559820Euphora™EUP1510X2016-04-25
00643169559837Euphora™EUP1512X2016-04-11
00643169559844Euphora™EUP1515X2016-04-11
00643169559851Euphora™EUP1520X2016-04-11
00643169559868Euphora™EUP2006X2016-04-11
00643169559875Euphora™EUP2010X2016-04-11
00643169559905Euphora™EUP2020X2016-04-11
00643169559912Euphora™EUP2025X2016-04-25
00643169559929Euphora™EUP2030X2016-04-11
00643169559936Euphora™EUP22506X2016-04-11
00643169559943Euphora™EUP22510X2016-04-11
00643169559950Euphora™EUP22512X2016-04-11
00643169559967Euphora™EUP22515X2016-04-11
00643169559974Euphora™EUP22520X2016-04-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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