FDA.reportPublic FDA data

NA

Primary DI
20763000076256
Brand
NA
Company
MEDTRONIC, INC.
Model
10H01R
Device description
CUSTOM PACK 10H01R 12PK TEMP PORT
Published
2017-12-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K800178000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K800178000EXTRACORP.'S INTERSEPT CUS. TUBING PK.Extracorporeal Medical Specialities, Inc.1980-02-21DWE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20763000076256PackageGS112In Commercial Distribution
00763000076245PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2076300007625620763000076256
00763000076245007630000762457630000762450763000076245

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass system tubing setA collection of sterile devices including tubing and typically clamps, filters, connectors, and stopcocks, used in a circuit for a cardiopulmonary bypass procedure. The tubing is typically polymeric and may be heparin coated. It is typically used in the blood pump head of a cardiopulmonary bypass system. The tubing, when used in a roller type pump, will be cyclically compressed by the blood pump to cause the blood to flow through the heart-lung bypass system. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius50 Degrees Celsius

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
true
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00613994391551NA6207-S52017-01-03
00613994391568NA6208-S52017-01-03
00613994391575NA6209-S52017-01-03
00613994391582NA6210-S52017-01-03
00613994397829NA6211-S52017-01-03
00643169002913Stretch™ Insertion Tool0060732016-07-02
00643169013964NA2082112017-02-02
00643169013988NA2072232017-02-03
00643169013995NA207211A2017-02-02
00643169014008NA2072112017-02-02
00643169014022NA2062232017-02-03
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

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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
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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