Mini ONE® Non-Balloon Button M1-1-1824-I
GUDID 00842071117719
18FR x 2.4 cm Mini ONE® Non-Balloon Button (Enfit)
APPLIED MEDICAL TECHNOLOGY, INC.
Gastrostomy button| Primary Device ID | 00842071117719 |
| NIH Device Record Key | 7035c692-7acf-42fb-a50e-c017dbb2f22a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Mini ONE® Non-Balloon Button |
| Version Model Number | M1-1-1824-I |
| Catalog Number | M1-1-1824-I |
| Company DUNS | 038101861 |
| Company Name | APPLIED MEDICAL TECHNOLOGY, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | (440)717-4000 |
| cs@appliedmedical.net |
Device Dimensions
| Catheter Gauge | 18 French |
| Catheter Gauge | 18 French |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00842071117719 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K980305
FDA Product Code
| KNT | Tubes, Gastrointestinal (And Accessories) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-10-07 |
| Device Publish Date | 2017-03-15 |
On-Brand Devices [Mini ONE® Non-Balloon Button]
| 00842071117825 | 24FR x 4.4 cm Mini ONE® Non-Balloon Button (Enfit) |
| 00842071117818 | 24FR x 3.4 cm Mini ONE® Non-Balloon Button (Enfit) |
| 00842071117801 | 24FR x 2.4 cm Mini ONE® Non-Balloon Button (Enfit) |
| 00842071117795 | 24FR x 1.7 cm Mini ONE® Non-Balloon Button (Enfit) |
| 00842071117788 | 20FR x 4.4 cm Mini ONE® Non-Balloon Button (Enfit) |
| 00842071117771 | 20FR x 3.4 cm Mini ONE® Non-Balloon Button (Enfit) |
| 00842071117764 | 20FR x 2.4 cm Mini ONE® Non-Balloon Button (Enfit) |
| 00842071117757 | 20FR x 1.7 cm Mini ONE® Non-Balloon Button (Enfit) |
| 00842071117740 | 18FR x 4.4 cm Mini ONE® Non-Balloon Button (Enfit) |
| 00842071117733 | 18FR x 3.4 cm Mini ONE® Non-Balloon Button (Enfit) |
| 00842071117726 | 18FR x 3.0 cm Mini ONE® Non-Balloon Button (Enfit) |
| 00842071117719 | 18FR x 2.4 cm Mini ONE® Non-Balloon Button (Enfit) |
| 00842071117702 | 18FR x 2.0 cm Mini ONE® Non-Balloon Button (Enfit) |
| 00842071117696 | 18FR x 1.7 cm Mini ONE® Non-Balloon Button (Enfit) |
| 00842071117689 | 18FR x 1.5 cm Mini ONE® Non-Balloon Button (Enfit) |
| 00842071117672 | 18FR x 1.2 cm Mini ONE® Non-Balloon Button (Enfit) |
| 00842071117665 | 14FR x 3.0 cm Mini ONE® Non-Balloon Button (Enfit) |
| 00842071117658 | 14FR x 2.5 cm Mini ONE® Non-Balloon Button (Enfit) |
| 00842071117641 | 14FR x 2.0 cm Mini ONE® Non-Balloon Button (Enfit) |
| 00842071117634 | 14FR x 1.7 cm Mini ONE® Non-Balloon Button (Enfit) |
| 00842071117627 | 14FR x 1.5 cm Mini ONE® Non-Balloon Button (Enfit) |
| 00842071117610 | 14FR x 1.2 cm Mini ONE® Non-Balloon Button (Enfit) |
| 00842071117603 | 14FR x 1.0 cm Mini ONE® Non-Balloon Button (Enfit) |
| 00842071101374 | 24FR x 4.4 cm Mini ONE® Non-Balloon Button |
| 00842071101367 | 24FR x 3.4 cm Mini ONE® Non-Balloon Button |
| 00842071101350 | 24FR x 2.4 cm Mini ONE® Non-Balloon Button |
| 00842071101343 | 24FR x 1.7 cm Mini ONE® Non-Balloon Button |
| 00842071101336 | 20FR x 4.4 cm Mini ONE® Non-Balloon Button |
| 00842071101329 | 20FR x 3.4 cm Mini ONE® Non-Balloon Button |
| 00842071101312 | 20FR x 2.4 cm Mini ONE® Non-Balloon Button |
| 00842071101305 | 20FR x 1.7 cm Mini ONE® Non-Balloon Button |
| 00842071101299 | 18FR x 4.4 cm Mini ONE® Non-Balloon Button |
| 00842071101282 | 18FR x 3.4 cm Mini ONE® Non-Balloon Button |
| 00842071101275 | 18FR x 3.0 cm Mini ONE® Non-Balloon Button |
| 00842071101268 | 18FR x 2.4 cm Mini ONE® Non-Balloon Button |
| 00842071101251 | 18FR x 2.0 cm Mini ONE® Non-Balloon Button |
| 00842071101244 | 18FR x 1.7 cm Mini ONE® Non-Balloon Button |
| 00842071101237 | 18FR x 1.5 cm Mini ONE® Non-Balloon Button |
| 00842071101220 | 18FR x 1.2 cm Mini ONE® Non-Balloon Button |
| 00842071101213 | 14FR x 3.0 cm Mini ONE® Non-Balloon Button |
| 00842071101206 | 14FR x 2.5 cm Mini ONE® Non-Balloon Button |
| 00842071101190 | 14FR x 2.0 cm Mini ONE® Non-Balloon Button |
| 00842071101183 | 14FR x 1.7 cm Mini ONE® Non-Balloon Button |
| 00842071101176 | 14FR x 1.5 cm Mini ONE® Non-Balloon Button |
| 00842071101169 | 14FR x 1.2 cm Mini ONE® Non-Balloon Button |
| 00842071101152 | 14FR x 1.0 cm Mini ONE® Non-Balloon Button |
Trademark Results [Mini ONE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MINI ONE 77188323 3547588 Live/Registered |
Applied Medical Technology, Inc. 2007-05-23 |
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