SJM™ IBI-85809

GUDID 05414734309110

IRVINE BIOMEDICAL, INC.

Electrical-only medical device connection cable, reprocessed
Primary Device ID05414734309110
NIH Device Record Key20f2bcac-cd66-4fd2-bd6b-078fd006b926
Commercial Distribution StatusIn Commercial Distribution
Brand NameSJM™
Version Model Number1804-S
Catalog NumberIBI-85809
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

Length5 Feet

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS105414734309110 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LPBCardiac ablation percutaneous catheter

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[05414734309110]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-01-28
Device Publish Date2015-02-05

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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