FDA.reportPublic FDA data

Custom Pack

Primary DI
00607567206571
Brand
Custom Pack
Company
DATASCOPE CORP.
Model
T 34104
Catalog number
701067412
Published
2017-03-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K053025000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K053025000JOSTRA HLM TUBING SETMaquet Cardiopulmonary, AG2005-11-10DWE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00607567206571PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00607567206571006075672065716075672065710607567206571

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 Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
18886278383cpsurgery@maquet.com

Regulatory Flags#

DUNS number
001660786
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10607567114170Insertion Kit with 6” (15cm) Introducer for use with Linear 7.5Fr. 25cc IAB0884-00-0019-12U0884-00-0019-12U2024-02-20
10607567114194Insertion Kit with 6” (15cm) Introducer for use with Linear 7.5Fr. 34cc & 40cc I0884-00-0019-13U0884-00-0019-13U2024-02-20
10607567114200Insertion Kit with 6” (15cm) Introducer for use with Sensation 7Fr. 34cc & 40cc0884-00-0019-16U0884-00-0019-16U2024-02-20
10607567114217Insertion Kit with 6” (15cm) Introducer for use with MEGA 8Fr. 50cc IAB0884-00-0019-17U0884-00-0019-17U2024-02-20
10607567114224Insertion Kit with 6” (15cm) Introducer for use with MEGA 7.5Fr. 30 & 40cc IABs0884-00-0019-21U0884-00-0019-21U2024-02-20
10607567114231Insertion Kit with 7.5Fr. 6” (15cm) Introducer for Use with the SENSATION PLUS 70884-00-0019-22U0884-00-0019-22U2024-02-20
10607567114248Insertion Kit with 8Fr. 6” (15cm) Introducer for Use with the SENSATION PLUS 8Fr0884-00-0019-23U0884-00-0019-23U2024-02-20
10607567106656Reinforced Introducer Set for Linear 7.5Fr & Mega 7.5Fr0684-00-0403-050684-00-0403-052023-03-14
10607567106694Reinforced Introducer Set for Sensation 7Fr0684-00-0403-060684-00-0403-062023-03-14
10607567107943Reinforced Introducer Set for Sensation Plus & Mega 8Fr0684-00-0403-100684-00-0403-102023-03-14
10607567106632Insertion Kit with 6” (15cm) Introducer for use with Linear 7.5Fr. 25cc IAB0884-00-0019-120884-00-0019-122016-09-16
10607567106649Insertion Kit with 6” (15cm) Introducer for use with Linear 7.5Fr. 34cc & 40cc I0884-00-0019-130884-00-0019-132016-09-16
10607567106724Insertion Kit with 6” (15cm) Introducer for use with Sensation 7Fr. 34cc & 40cc0884-00-0019-160884-00-0019-162016-09-16
10607567107493Insertion Kit with 6” (15cm) Introducer for use with MEGA 8Fr. 50cc IAB0884-00-0019-170884-00-0019-172016-09-16
10607567108025Insertion Kit with 6” (15cm) Introducer for use with MEGA 7.5Fr. 30 & 40cc IABs0884-00-0019-210884-00-0019-212016-09-16
10607567108599Insertion Kit with 8Fr. 6” (15cm) Introducer for Use with the SENSATION PLUS 8Fr0884-00-0019-230884-00-0019-232016-09-16
10607567108612Insertion Kit with 7.5Fr. 6” (15cm) Introducer for Use with the SENSATION PLUS 70884-00-0019-220884-00-0019-222016-09-16
10607567510996TigerPaw Pro Left Atrial Appendage Closure Device35mm7500010992020-11-18
10607567107301MEGA 8Fr. 50cc IAB0684-00-0498-010684-00-0498-012016-09-15
10607567107318MEGA 8Fr. 50cc IAB (with APA)0684-00-0498-020684-00-0498-022016-09-15

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00803622165047Perfusion PackLIVANOVA USA, INC.DWE2026-10-19
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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