SJM™ IBI-85778

GUDID 05414734309073

IRVINE BIOMEDICAL, INC.

Electrical-only medical device connection cable, reprocessed Electrical-only medical device connection cable, reprocessed Electrical-only medical device connection cable, reprocessed Electrical-only medical device connection cable, reprocessed Electrical-only medical device connection cable, reprocessed Electrical-only medical device connection cable, reprocessed Electrical-only medical device connection cable, reprocessed Electrical-only medical device connection cable, reprocessed Electrical-only medical device connection cable, reprocessed Electrical-only medical device connection cable, reprocessed Electrical-only medical device connection cable, reprocessed Electrical-only medical device connection cable, reprocessed Electrical-only medical device connection cable, reprocessed Electrical-only medical device connection cable, reprocessed Electrical-only medical device connection cable, reprocessed Electrical-only medical device connection cable, reprocessed Electrical-only medical device connection cable, reprocessed Electrical-only medical device connection cable, reprocessed Electrical-only medical device connection cable, reprocessed Electrical-only medical device connection cable, reprocessed Electrical-only medical device connection cable, reprocessed Electrical-only medical device connection cable, reprocessed Electrical-only medical device connection cable, reprocessed Electrical-only medical device connection cable, reprocessed Electrical-only medical device connection cable, reprocessed Electrical-only medical device connection cable, reprocessed Electrical-only medical device connection cable, reprocessed Electrical-only medical device connection cable, reprocessed Electrical-only medical device connection cable, reprocessed Electrical-only medical device connection cable, reprocessed Electrical-only medical device connection cable, reprocessed Electrical-only medical device connection cable, reprocessed
Primary Device ID05414734309073
NIH Device Record Key36ca6e7b-23b7-4639-8eac-5e23b59014ee
Commercial Distribution StatusIn Commercial Distribution
Brand NameSJM™
Version Model Number1778-E
Catalog NumberIBI-85778
Company DUNS926346966
Company NameIRVINE BIOMEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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

Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com

Device Dimensions

Length8 Feet
Length8 Feet
Length8 Feet
Length8 Feet
Length8 Feet
Length8 Feet
Length8 Feet
Length8 Feet
Length8 Feet
Length8 Feet
Length8 Feet
Length8 Feet
Length8 Feet
Length8 Feet
Length8 Feet
Length8 Feet
Length2.5 Meter
Length8 Feet
Length2.5 Meter
Length8 Feet
Length2.5 Meter
Length8 Feet
Length2.5 Meter
Length8 Feet
Length2.5 Meter
Length8 Feet
Length2.5 Meter
Length8 Feet
Length2.5 Meter
Length8 Feet
Length2.5 Meter
Length8 Feet
Length2.5 Meter
Length8 Feet
Length2.5 Meter
Length8 Feet
Length2.5 Meter
Length8 Feet
Length2.5 Meter
Length8 Feet
Length2.5 Meter
Length8 Feet
Length2.5 Meter
Length8 Feet
Length2.5 Meter
Length8 Feet
Length2.5 Meter
Length8 Feet
Length2.5 Meter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool,dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool,dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool,dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool,dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool,dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool,dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool,dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool,dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool,dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool,dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool,dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool,dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool,dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool,dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool,dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry. Keep away from sunlight.

Device Identifiers

Device Issuing AgencyDevice ID
GS105414734309073 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OADcatheter, percutaneous, cardiac ablation, for treatment of atrial flutter

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[05414734309073]

Ethylene Oxide

[05414734309073]

Ethylene Oxide

[05414734309073]

Ethylene Oxide

[05414734309073]

Ethylene Oxide

[05414734309073]

Ethylene Oxide

[05414734309073]

Ethylene Oxide

[05414734309073]

Ethylene Oxide

[05414734309073]

Ethylene Oxide

[05414734309073]

Ethylene Oxide

[05414734309073]

Ethylene Oxide

[05414734309073]

Ethylene Oxide

[05414734309073]

Ethylene Oxide

[05414734309073]

Ethylene Oxide

[05414734309073]

Ethylene Oxide

[05414734309073]

Ethylene Oxide

[05414734309073]

Ethylene Oxide

[05414734309073]

Ethylene Oxide

[05414734309073]

Ethylene Oxide

[05414734309073]

Ethylene Oxide

[05414734309073]

Ethylene Oxide

[05414734309073]

Ethylene Oxide

[05414734309073]

Ethylene Oxide

[05414734309073]

Ethylene Oxide

[05414734309073]

Ethylene Oxide

[05414734309073]

Ethylene Oxide

[05414734309073]

Ethylene Oxide

[05414734309073]

Ethylene Oxide

[05414734309073]

Ethylene Oxide

[05414734309073]

Ethylene Oxide

[05414734309073]

Ethylene Oxide

[05414734309073]

Ethylene Oxide

[05414734309073]

Ethylene Oxide

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-01-28
Device Publish Date2014-10-31

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054147343089771763-E
054147343089391739-W
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054147343088471711-M
054147343088301710
054147343087551641
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