CORODYN 601190-02

GUDID 04046955651580

CORODYN P1 F7 110CM WEDGE PRESS BALLOON

B. BRAUN MEDICAL INC.

Coronary sinus venogram catheter Coronary sinus venogram catheter Coronary sinus venogram catheter Coronary sinus venogram catheter Coronary sinus venogram catheter Coronary sinus venogram catheter Coronary sinus venogram catheter Coronary sinus venogram catheter Coronary sinus venogram catheter Coronary sinus venogram catheter Coronary sinus venogram catheter Coronary sinus venogram catheter Coronary sinus venogram catheter Coronary sinus venogram catheter Coronary sinus venogram catheter Coronary sinus venogram catheter Coronary sinus venogram catheter Coronary sinus venogram catheter Coronary sinus venogram catheter Coronary sinus venogram catheter Coronary sinus venogram catheter Coronary sinus venogram catheter
Primary Device ID04046955651580
NIH Device Record Keyf18518fa-75e1-4417-a88d-c435d3925e71
Commercial Distribution StatusIn Commercial Distribution
Brand NameCORODYN
Version Model Number601190-02
Catalog Number601190-02
Company DUNS002397347
Company NameB. BRAUN MEDICAL INC.
Device Count5
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)227-2862
EmailBBMUS_Service.EmailOrders@bbraun.com
Phone+1(800)227-2862
EmailBBMUS_Service.EmailOrders@bbraun.com
Phone+1(800)227-2862
EmailBBMUS_Service.EmailOrders@bbraun.com
Phone+1(800)227-2862
EmailBBMUS_Service.EmailOrders@bbraun.com
Phone+1(800)227-2862
EmailBBMUS_Service.EmailOrders@bbraun.com
Phone+1(800)227-2862
EmailBBMUS_Service.EmailOrders@bbraun.com
Phone+1(800)227-2862
EmailBBMUS_Service.EmailOrders@bbraun.com
Phone+1(800)227-2862
EmailBBMUS_Service.EmailOrders@bbraun.com
Phone+1(800)227-2862
EmailBBMUS_Service.EmailOrders@bbraun.com
Phone+1(800)227-2862
EmailBBMUS_Service.EmailOrders@bbraun.com
Phone+1(800)227-2862
EmailBBMUS_Service.EmailOrders@bbraun.com
Phone+1(800)227-2862
EmailBBMUS_Service.EmailOrders@bbraun.com
Phone+1(800)227-2862
EmailBBMUS_Service.EmailOrders@bbraun.com
Phone+1(800)227-2862
EmailBBMUS_Service.EmailOrders@bbraun.com
Phone+1(800)227-2862
EmailBBMUS_Service.EmailOrders@bbraun.com
Phone+1(800)227-2862
EmailBBMUS_Service.EmailOrders@bbraun.com
Phone+1(800)227-2862
EmailBBMUS_Service.EmailOrders@bbraun.com
Phone+1(800)227-2862
EmailBBMUS_Service.EmailOrders@bbraun.com
Phone+1(800)227-2862
EmailBBMUS_Service.EmailOrders@bbraun.com
Phone+1(800)227-2862
EmailBBMUS_Service.EmailOrders@bbraun.com
Phone+1(800)227-2862
EmailBBMUS_Service.EmailOrders@bbraun.com
Phone+1(800)227-2862
EmailBBMUS_Service.EmailOrders@bbraun.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE BETWEEN 15 - 30 °C
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE BETWEEN 15 - 30 °C
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE BETWEEN 15 - 30 °C
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE BETWEEN 15 - 30 °C
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE BETWEEN 15 - 30 °C
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE BETWEEN 15 - 30 °C
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE BETWEEN 15 - 30 °C
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE BETWEEN 15 - 30 °C
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE BETWEEN 15 - 30 °C
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A DRY PLACE
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A DRY PLACE
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A DRY PLACE
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A DRY PLACE
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A DRY PLACE
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A DRY PLACE
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A DRY PLACE
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A DRY PLACE
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A DRY PLACE
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A DRY PLACE
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A DRY PLACE
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A DRY PLACE
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A DRY PLACE
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A DRY PLACE

Device Identifiers

Device Issuing AgencyDevice ID
GS104046955651580 [Unit of Use]
GS104046955651597 [Primary]

FDA Product Code

DYGCATHETER, FLOW DIRECTED

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-25
Device Publish Date2021-08-17

On-Brand Devices [CORODYN]

04046955651962CORODYN P1 F6 60CM WEDGE PRESS BALLOON
04046955651726ANGIOGRAPHY BALLOON CATH 6FR 90CM FG
04046955651665ANGIOGRAPHY BALLOON CATH 7FR 110CM FG
04046955651641ANGIOGRAPHIC BALLOON CATH 5FX80CM FG
04046955651627CORODYN P1 F6 110CM WEDGE PRESS BALLOON
04046955651580CORODYN P1 F7 110CM WEDGE PRESS BALLOON
04046955651542CORODYN P1 F5 110CM WEDGE PRESS BALLOON
04046955651702ANGIOGRAPHY BALLOON CATH 6FR 60CM FG
04046955651689ANGIOGRAPHY BALLOON CATH 5FR 50CM FG
04046955651566CORODYN P1 F5 60CM WEDGE PRESS BALLOON

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