Kodiak 381416000
GUDID 00886333225743
Kodiak™ Dual Port Coaxial Introducer Kit
ARGON MEDICAL DEVICES, INC.
Vascular catheter introduction set, nonimplantable| Primary Device ID | 00886333225743 |
| NIH Device Record Key | e80d7024-daef-4175-958d-20f4095f1176 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Kodiak |
| Version Model Number | 381416000 |
| Catalog Number | 381416000 |
| Company DUNS | 140727624 |
| Company Name | ARGON MEDICAL DEVICES, 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
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00886333225743 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K230631
FDA Product Code
| DYB | Introducer, Catheter |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-10 |
| Device Publish Date | 2023-06-30 |
Devices Manufactured by ARGON MEDICAL DEVICES, INC.
| 20886333227659 - Transfermoral Transcaval Liver Biopsy System | 2024-08-20 Transfermoral Transcaval Liver Biopsy System |
| 20886333227499 - ClosureFast Guidewire | 2024-08-06 ClosureFast™ Guidewire J Tip, PTFE, Fixed Core, 0.025" (0.64mm) x 260cm |
| 20886333227505 - ClosureFast Guidewire | 2024-08-06 ClosureFast™ Guidewire Double Ended, PTFE, Fixed Core 0.035" (0.89mm) x 45cm |
| 20886333227512 - ClosureFast Introducer Sheath | 2024-08-06 ClosureFast Introducer Sheath Set 7Fr/Ch (2.3mm) x 7cm |
| 20886333227529 - ClosureFast Introducer Sheath | 2024-08-06 ClosureFast™ Introducer Sheath Set 7Fr/Ch (2.3mm) x 11cm |
| 20886333227550 - ClosureFast Micro Puncture | 2024-08-06 ClosureFast™ Micro Puncture Kit 4Fr/Ch (1.3mm) |
| 20886333227567 - ClosureFast Micro Puncture | 2024-08-06 ClosureFast™ Micro Puncture Kit 5Fr/Ch (1.7mm) |
| 20886333227574 - ClosureFast Tumescent Infiltration Kit | 2024-08-06 ClosureFast™ Tumescent Infiltration Kit |
Trademark Results [Kodiak]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 KODIAK 98702600 not registered Live/Pending |
IW Apparel, LLC 2024-08-16 |
 KODIAK 98702597 not registered Live/Pending |
IW Apparel, LLC 2024-08-16 |
 KODIAK 98584126 not registered Live/Pending |
Core SWX, LLC 2024-06-04 |
 KODIAK 98495407 not registered Live/Pending |
Agora Kodiak Leather LLC 2024-04-11 |
 KODIAK 98483158 not registered Live/Pending |
Rosswil, LLC 2024-04-03 |
 KODIAK 98483155 not registered Live/Pending |
Rosswil, LLC 2024-04-03 |
 KODIAK 98437244 not registered Live/Pending |
Kodiak Solutions LLC 2024-03-06 |
 KODIAK 98211455 not registered Live/Pending |
C3 Ventures LLC 2023-10-05 |
 KODIAK 97840722 not registered Live/Pending |
M Chemical Company, Inc. 2023-03-15 |
 KODIAK 97779713 not registered Live/Pending |
Luminor Environmental Inc. 2023-02-03 |
 KODIAK 97534731 not registered Live/Pending |
Extract Production Services, LLC 2022-08-04 |
 KODIAK 97520407 not registered Live/Pending |
Ducan Industries Ltd. 2022-07-26 |
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