Cleaner Plus™ 70011510
GUDID 00886333225767
Cleaner Plus™ Thrombectomy System 10F (OD) x 135cm
ARGON MEDICAL DEVICES, INC.
Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter| Primary Device ID | 00886333225767 |
| NIH Device Record Key | ec638690-e8c3-4797-bed9-46d01f842dfa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cleaner Plus™ |
| Version Model Number | 70011510 |
| Catalog Number | 70011510 |
| 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 | true |
| 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
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
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 |
| 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 | 00886333225767 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K211798
FDA Product Code
| KRA | Catheter, Continuous Flush |
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 | 2022-03-08 |
| Device Publish Date | 2022-02-28 |
On-Brand Devices [Cleaner Plus™]
| 00886333225781 | Cleaner Plus™ Thrombectomy System 12F (OD) x 135cm |
| 00886333225774 | Cleaner Plus™ Thrombectomy System 12F (OD) x 65cm |
| 00886333225767 | Cleaner Plus™ Thrombectomy System 10F (OD) x 135cm |
| 00886333225750 | Cleaner Plus™ Thrombectomy System 10F (OD) x 65cm |
Trademark Results [Cleaner Plus]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CLEANER PLUS 90690124 not registered Live/Pending |
Argon Medical Devices, Inc. 2021-05-04 |
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