Insertion Kit with 6” (15cm) Introducer for use with Linear 7.5Fr. 34cc & 40cc I 0884-00-0019-13

GUDID 10607567106649

Insertion Kit with 6” (15cm) Introducer for use with Linear 7.5Fr. 34cc & 40cc IABs

DATASCOPE CORP.

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Primary Device ID10607567106649
NIH Device Record Keyc8a9056f-37b9-45e8-a51c-f4188c99197e
Commercial Distribution StatusIn Commercial Distribution
Brand NameInsertion Kit with 6” (15cm) Introducer for use with Linear 7.5Fr. 34cc & 40cc I
Version Model Number0884-00-0019-13
Catalog Number0884-00-0019-13
Company DUNS001660786
Company NameDATASCOPE CORP.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
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
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
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 Dimensions

Catheter Gauge7.5 French
Catheter Gauge7.5 French
Catheter Gauge7.5 French
Catheter Gauge7.5 French
Catheter Gauge7.5 French
Catheter Gauge7.5 French
Catheter Gauge7.5 French
Catheter Gauge7.5 French
Catheter Gauge7.5 French
Catheter Gauge7.5 French
Catheter Gauge7.5 French
Catheter Gauge7.5 French
Catheter Gauge7.5 French
Catheter Gauge7.5 French
Catheter Gauge7.5 French
Catheter Gauge7.5 French
Catheter Gauge7.5 French
Catheter Gauge7.5 French
Catheter Gauge7.5 French
Catheter Gauge7.5 French
Catheter Gauge7.5 French
Catheter Gauge7.5 French
Catheter Gauge7.5 French
Catheter Gauge7.5 French
Catheter Gauge7.5 French
Catheter Gauge7.5 French
Catheter Gauge7.5 French
Catheter Gauge7.5 French
Catheter Gauge7.5 French
Catheter Gauge7.5 French
Catheter Gauge7.5 French
Catheter Gauge7.5 French

Device Identifiers

Device Issuing AgencyDevice ID
GS110607567106649 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DSPSystem, Balloon, Intra-Aortic And Control

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10607567106649]

Ethylene Oxide

[10607567106649]

Ethylene Oxide

[10607567106649]

Ethylene Oxide

[10607567106649]

Ethylene Oxide

[10607567106649]

Ethylene Oxide

[10607567106649]

Ethylene Oxide

[10607567106649]

Ethylene Oxide

[10607567106649]

Ethylene Oxide

[10607567106649]

Ethylene Oxide

[10607567106649]

Ethylene Oxide

[10607567106649]

Ethylene Oxide

[10607567106649]

Ethylene Oxide

[10607567106649]

Ethylene Oxide

[10607567106649]

Ethylene Oxide

[10607567106649]

Ethylene Oxide

[10607567106649]

Ethylene Oxide

[10607567106649]

Ethylene Oxide

[10607567106649]

Ethylene Oxide

[10607567106649]

Ethylene Oxide

[10607567106649]

Ethylene Oxide

[10607567106649]

Ethylene Oxide

[10607567106649]

Ethylene Oxide

[10607567106649]

Ethylene Oxide

[10607567106649]

Ethylene Oxide

[10607567106649]

Ethylene Oxide

[10607567106649]

Ethylene Oxide

[10607567106649]

Ethylene Oxide

[10607567106649]

Ethylene Oxide

[10607567106649]

Ethylene Oxide

[10607567106649]

Ethylene Oxide

[10607567106649]

Ethylene Oxide

[10607567106649]

Ethylene Oxide

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-06-07
Device Publish Date2016-09-16

On-Brand Devices [Insertion Kit with 6” (15cm) Introducer for use with Linear 7.5Fr. 34cc & 40cc I]

10607567106649Insertion Kit with 6” (15cm) Introducer for use with Linear 7.5Fr. 34cc & 40cc IABs
10607567114194Insertion Kit with 6” (15cm) Introducer for use with Linear 7.5Fr. 34cc & 40cc IABs
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