Cleaner Plus™ 70001512
GUDID 00886333225774
Cleaner Plus™ Thrombectomy System 12F (OD) x 65cm
ARGON MEDICAL DEVICES, INC.
Thrombectomy suction catheter| Primary Device ID | 00886333225774 |
| NIH Device Record Key | 7daa9139-8fbb-44ae-9a5b-1bc7b18481e5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cleaner Plus™ |
| Version Model Number | 70001512 |
| Catalog Number | 70001512 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
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 |
| 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 | 00886333225774 [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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.