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
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