SJM™ IBI-85713

GUDID 05414734308854

IRVINE BIOMEDICAL, INC.

Electrical-only medical device connection cable, reprocessed
Primary Device ID05414734308854
NIH Device Record Key3f941d94-3aa5-490b-b1d9-7c145a020b0f
Commercial Distribution StatusIn Commercial Distribution
Brand NameSJM™
Version Model Number1713-W
Catalog NumberIBI-85713
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

Device Dimensions

Length8 Feet

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS105414734308854 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LPBCardiac ablation percutaneous catheter

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[05414734308854]

Ethylene Oxide


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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.