Inquiry™ IBI-80627
GUDID 05414734302203
IRVINE BIOMEDICAL, INC.
Cardiac mapping catheter, percutaneous, single-use| Primary Device ID | 05414734302203 |
| NIH Device Record Key | 45bb3cd8-9e56-4fbd-9b85-b671fe9f7520 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Inquiry™ |
| Version Model Number | IBI-80627 |
| Catalog Number | IBI-80627 |
| Company DUNS | 926346966 |
| Company Name | IRVINE BIOMEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(855)478-5833 |
| customerservice@sjm.com |
Device Dimensions
| Catheter Gauge | 5 French |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry location. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05414734302203 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K946333
FDA Product Code
| DRF | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-03-20 |
On-Brand Devices [Inquiry™]
Trademark Results [Inquiry]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INQUIRY 86078860 not registered Dead/Abandoned |
The Learning Internet, Inc. 2013-09-30 |
 INQUIRY 85580396 4233939 Live/Registered |
St. Jude Medical, Atrial Fibrillation Division, Inc. 2012-03-26 |
 INQUIRY 76633860 3139673 Live/Registered |
ST. JUDE MEDICAL, ATRIAL FIBRILLATION DIVISION, INC. 2005-03-21 |
 INQUIRY 74704302 not registered Dead/Abandoned |
inquiry.com inc. 1995-07-20 |
 INQUIRY 74372483 1898366 Dead/Cancelled |
PARSONS, McKEE, SOMMERS and COMPANY 1993-03-29 |
 INQUIRY 74356532 not registered Dead/Abandoned |
PARSONS, McKEE, SOMMERS and COMPANY 1993-02-08 |
 INQUIRY 73353509 1246036 Dead/Cancelled |
Inquiry 1982-03-08 |
 INQUIRY 73103554 1066987 Dead/Expired |
INQUIRY 1976-10-18 |
 INQUIRY 72288934 0871806 Live/Registered |
BLUE CROSS ASSOCIATION 1968-01-16 |
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