SJM™ IBI-85786

GUDID 05414734309080

IRVINE BIOMEDICAL, INC.

Electrical catheter connection cable, reusable
Primary Device ID05414734309080
NIH Device Record Keya717f41c-e289-4bbe-9b86-f1d2e76c1fdd
Commercial Distribution StatusIn Commercial Distribution
Brand NameSJM™
Version Model NumberIBI-85786
Catalog NumberIBI-85786
Company DUNS926346966
Company NameIRVINE BIOMEDICAL, INC.
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

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

Length20 Feet
Length20 Feet
Length20 Feet
Length20 Feet
Length20 Feet
Length20 Feet
Length20 Feet
Length20 Feet
Length20 Feet
Length20 Feet
Length20 Feet
Length20 Feet
Length20 Feet
Length20 Feet
Length20 Feet
Length20 Feet
Length20 Feet

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in a cool, dry place

Device Identifiers

Device Issuing AgencyDevice ID
GS105414734309080 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

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

On-Brand Devices [SJM™]

054147343093491914-SA
054147343093321910-SA
054147343093181904-SA
054147343091721924-S
054147343091651910-S
054147343091101804-S
05414734309080IBI-85786
054147343090731778-E
054147343090591776
054147343089771763-E
054147343089391739-W
054147343088541713-W
054147343088471711-M
054147343088301710
054147343087551641

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