FDA.reportPublic FDA data

Cardioplegia Accessory Pack

Primary DI
00607567205802
Brand
Cardioplegia Accessory Pack
Company
DATASCOPE CORP.
Model
BO-T 30301
Catalog number
701066188
Published
2016-07-11
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
DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00607567205802PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00607567205802006075672058026075672058020607567205802

GMDN Terms#

Term, Definition table
TermDefinition
Cardioplegia solution administration kitA collection of sterile devices intended to be used to inject cardioplegia solution into the heart to interrupt its contractions during cardiopulmonary bypass surgery. It typically consists of tubing/adaptor, a filter, and a heat exchanger. This is 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
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
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
10607567107479Arrow Pump Adapter - 5 Pack - for use with the Mega 8 Fr. 50cc IAB only0684-00-0510-020684-00-0510-022016-09-23
10607567107516Catheter Extenders for 50cc IAB’s 0684-00-05260684-00-05262016-09-14
10607567108001MEGA 8Fr. 50cc IAB (with Statlock)0684-00-0296-010684-00-0296-012016-09-15
10607567108018MEGA 8Fr. 50cc IAB (with Statlock & APA)0684-00-0296-020684-00-0296-022016-09-15
10607567108063SENSATION PLUS 7.5Fr. 40cc IAB & Accessories0684-00-0568-010684-00-0568-012016-09-15
10607567108605SENSATION PLUS 8Fr. 50cc IAB & Accessories (w/Pressure Tubes, No Stylet)0684-00-0576-010684-00-0576-012016-09-15
10607567109381Sensation Plus 8Fr 50cc IAB With Accessories (w/Pressure Tubes, No Stylet, w/o S0684-00-0576-050684-00-0576-052016-09-15
10607567109411MEGA 8Fr. 50cc IAB (W/O Statlock)0684-00-0296-030684-00-0296-032016-09-15
10607567109428Sensation Plus 7.5Fr. 40cc IAB (W/O Statlock)0684-00-0568-030684-00-0568-032016-09-15
10607567109435Sensation Plus 8Fr. 50cc IAB (W/O Statlock)0684-00-0576-030684-00-0576-032016-09-15
10607567109442Sensation Plus 7.5Fr. 40cc IAB W/ Accessories (W/O Statlock)(China)0684-00-0568-050684-00-0568-052016-09-15
10607567109565Sensation Plus 7.5Fr. 40cc IAB with Accessories, US Only0684-00-0568-01U0684-00-0568-01U2016-09-15
10607567109619MEGA 8Fr. 50cc IAB with Accessories, US Only0684-00-0296-01U0684-00-0296-01U2016-09-16
10607567109626MEGA 8Fr. 50cc IAB with Accessories (APA), US Only0684-00-0296-02U0684-00-0296-02U2016-09-16

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00840479401430enableCV EZ Glide Aortic CannulaENABLECV INC.DWF2026-07-09
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