FDA.reportPublic FDA data

NA

Primary DI
10673978522477
Brand
NA
Company
MEDTRONIC, INC.
Model
BT926
Device description
ADAPTER Y BT926 CARDIOTOMY 20PK
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
10673978522477PrimaryGS10
00673978522470Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1067397852247710673978522477
00673978522470006739785224706739785224700673978522470

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
20
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000422615SYNCHROMED®II8637-402021-04-11
00763000634094SYNCHROMED® II8637-202022-08-11
00763000634100SYNCHROMED® II8637-402022-08-11
00643169508149SYNCHROMED® II8637-202016-04-27
00643169508156SYNCHROMED® II8637-402016-04-27
00643169630505SYNCHROMED® II8637-202018-08-17
00643169630512SYNCHROMED® II8637-402018-08-17
00643169100824SYNCHROMED ® II8637-402016-04-27
00643169100831SYNCHROMED ® II8637-202016-04-27
00199150084036MiniMed Flex Starter KitMMT-8076B2026-07-19
00199150084043MiniMed Flex Starter KitMMT-8076C2026-07-19
00199150084050MiniMed Extended Supply KitMMT-445B2026-07-19
00199150084067MiniMed Extended Supply KitMMT-445C2026-07-19
00824846004721NABB12S95R52026-07-19
00824846004738NABB12S26R2026-07-19
00824846004028NABB5722R492026-07-16
00824846003151NABB9F19R82026-07-09
00763000520083N/AA712002021-07-23
00643169711761Micra™MC1VR01US2018-01-13
00824846003472NABB10L84R92026-07-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00613994946331Intersept®MEDTRONIC, INC.DWE2016-05-28
00643169021358INTERSEPT®MEDTRONIC, INC.DWE2016-05-28
00643169029125INTERSEPT®MEDTRONIC, INC.DWE2016-05-28
00643169061866INTERSEPT®MEDTRONIC, INC.DWE2016-05-28