JADA System

GUDID 60840164521131

Vacuum-induced Hemorrhage Control System

Organon LLC

Intrauterine haemostatic suction catheter Intrauterine haemostatic suction catheter Intrauterine haemostatic suction catheter Intrauterine haemostatic suction catheter Intrauterine haemostatic suction catheter Intrauterine haemostatic suction catheter Intrauterine haemostatic suction catheter Intrauterine haemostatic suction catheter Intrauterine haemostatic suction catheter Intrauterine haemostatic suction catheter Intrauterine haemostatic suction catheter Intrauterine haemostatic suction catheter Intrauterine haemostatic suction catheter Intrauterine haemostatic suction catheter Intrauterine haemostatic suction catheter Intrauterine haemostatic suction catheter Intrauterine haemostatic suction catheter Intrauterine haemostatic suction catheter
Primary Device ID60840164521131
NIH Device Record Keydc360da0-91a5-4044-b8ff-1eddc611c96b
Commercial Distribution StatusIn Commercial Distribution
Brand NameJADA System
Version Model NumberJADA-2002
Company DUNS117494753
Company NameOrganon LLC
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(844)674-3200
Emaildpoc.us@organon.com
Phone+1(844)674-3200
Emaildpoc.us@organon.com
Phone+1(844)674-3200
Emaildpoc.us@organon.com
Phone+1(844)674-3200
Emaildpoc.us@organon.com
Phone+1(844)674-3200
Emaildpoc.us@organon.com
Phone+1(844)674-3200
Emaildpoc.us@organon.com
Phone+1(844)674-3200
Emaildpoc.us@organon.com
Phone+1(844)674-3200
Emaildpoc.us@organon.com
Phone+1(844)674-3200
Emaildpoc.us@organon.com
Phone+1(844)674-3200
Emaildpoc.us@organon.com
Phone+1(844)674-3200
Emaildpoc.us@organon.com
Phone+1(844)674-3200
Emaildpoc.us@organon.com
Phone+1(844)674-3200
Emaildpoc.us@organon.com
Phone+1(844)674-3200
Emaildpoc.us@organon.com
Phone+1(844)674-3200
Emaildpoc.us@organon.com
Phone+1(844)674-3200
Emaildpoc.us@organon.com
Phone+1(844)674-3200
Emaildpoc.us@organon.com
Phone+1(844)674-3200
Emaildpoc.us@organon.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Do not store in direct sunlight. Store in original packaging in a dry location. Do not use if package is damaged. Consult instructions for use.
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Do not store in direct sunlight. Store in original packaging in a dry location. Do not use if package is damaged. Consult instructions for use.
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Do not store in direct sunlight. Store in original packaging in a dry location. Do not use if package is damaged. Consult instructions for use.
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Do not store in direct sunlight. Store in original packaging in a dry location. Do not use if package is damaged. Consult instructions for use.
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Do not store in direct sunlight. Store in original packaging in a dry location. Do not use if package is damaged. Consult instructions for use.
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Do not store in direct sunlight. Store in original packaging in a dry location. Do not use if package is damaged. Consult instructions for use.
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Do not store in direct sunlight. Store in original packaging in a dry location. Do not use if package is damaged. Consult instructions for use.
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Do not store in direct sunlight. Store in original packaging in a dry location. Do not use if package is damaged. Consult instructions for use.
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Do not store in direct sunlight. Store in original packaging in a dry location. Do not use if package is damaged. Consult instructions for use.
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Do not store in direct sunlight. Store in original packaging in a dry location. Do not use if package is damaged. Consult instructions for use.
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Do not store in direct sunlight. Store in original packaging in a dry location. Do not use if package is damaged. Consult instructions for use.
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Do not store in direct sunlight. Store in original packaging in a dry location. Do not use if package is damaged. Consult instructions for use.
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Do not store in direct sunlight. Store in original packaging in a dry location. Do not use if package is damaged. Consult instructions for use.
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Do not store in direct sunlight. Store in original packaging in a dry location. Do not use if package is damaged. Consult instructions for use.
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Do not store in direct sunlight. Store in original packaging in a dry location. Do not use if package is damaged. Consult instructions for use.
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Do not store in direct sunlight. Store in original packaging in a dry location. Do not use if package is damaged. Consult instructions for use.
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Do not store in direct sunlight. Store in original packaging in a dry location. Do not use if package is damaged. Consult instructions for use.
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Do not store in direct sunlight. Store in original packaging in a dry location. Do not use if package is damaged. Consult instructions for use.

Device Identifiers

Device Issuing AgencyDevice ID
GS100840164521139 [Primary]
GS160840164521131 [Package]
Contains: 00840164521139
Package: case [3 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OQYIntrauterine tamponade balloon

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-02-23
Device Publish Date2023-02-15

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60840164521131 - JADA System2023-02-23Vacuum-induced Hemorrhage Control System
60840164521131 - JADA System2023-02-23 Vacuum-induced Hemorrhage Control System
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