CABLE,ECG LEAD,OR,5L,IEC 0012-00-1814-02

GUDID 10607567112268

CABLE,ECG LEAD,OR,5L,IEC

Datascope Corp.

Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable
Primary Device ID10607567112268
NIH Device Record Key1d1d66d9-961d-4d79-b43a-1e9affbc0b59
Commercial Distribution StatusIn Commercial Distribution
Brand NameCABLE,ECG LEAD,OR,5L,IEC
Version Model Number0012-00-1814-02
Catalog Number0012-00-1814-02
Company DUNS040874329
Company NameDatascope Corp.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110607567112268 [Primary]

FDA Product Code

DSPSystem, Balloon, Intra-Aortic And Control

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-12-06
Device Publish Date2016-09-19

Devices Manufactured by Datascope Corp.

10607567114170 - Insertion Kit with 6” (15cm) Introducer for use with Linear 7.5Fr. 25cc IAB2024-02-28 Insertion Kit with 6” (15cm) Introducer for use with Linear 7.5Fr. 25cc IAB
10607567114194 - Insertion Kit with 6” (15cm) Introducer for use with Linear 7.5Fr. 34cc & 40cc I2024-02-28 Insertion Kit with 6” (15cm) Introducer for use with Linear 7.5Fr. 34cc & 40cc IABs
10607567114200 - Insertion Kit with 6” (15cm) Introducer for use with Sensation 7Fr. 34cc & 40cc 2024-02-28 Insertion Kit with 6” (15cm) Introducer for use with Sensation 7Fr. 34cc & 40cc IABs
10607567114217 - Insertion Kit with 6” (15cm) Introducer for use with MEGA 8Fr. 50cc IAB2024-02-28 Insertion Kit with 6” (15cm) Introducer for use with MEGA 8Fr. 50cc IAB
10607567114224 - Insertion Kit with 6” (15cm) Introducer for use with MEGA 7.5Fr. 30 & 40cc IABs2024-02-28 Insertion Kit with 6” (15cm) Introducer for use with MEGA 7.5Fr. 30 & 40cc IABs
10607567114231 - Insertion Kit with 7.5Fr. 6” (15cm) Introducer for Use with the SENSATION PLUS 72024-02-28 Insertion Kit with 7.5Fr. 6” (15cm) Introducer for Use with the SENSATION PLUS 7.5Fr 40cc IAB
10607567114248 - Insertion Kit with 8Fr. 6” (15cm) Introducer for Use with the SENSATION PLUS 8Fr2024-02-28 Insertion Kit with 8Fr. 6” (15cm) Introducer for Use with the SENSATION PLUS 8Fr 50cc IAB
10607567113128 - Sensation 7Fr 34cc IAB with Accessories (Turkey)2023-05-16 Sensation 7Fr 34cc IAB with Accessories (Turkey)
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.