Mini ONE® Capsule Non-Balloon Button M1-2-1420-I
GUDID 00842071117870
14FR x 2.0 cm Mini ONE® Capsule Non-Balloon Button (Enfit)
APPLIED MEDICAL TECHNOLOGY, INC.
Gastrostomy button| Primary Device ID | 00842071117870 |
| NIH Device Record Key | 17fbfa35-fe0a-4bf3-9e9d-cfb009d0fa4c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Mini ONE® Capsule Non-Balloon Button |
| Version Model Number | M1-2-1420-I |
| Catalog Number | M1-2-1420-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 | 14 French |
| Catheter Gauge | 14 French |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00842071117870 [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® Capsule Non-Balloon Button]
| 00842071118051 | 24FR x 4.4 cm Mini ONE® Capsule Non-Balloon Button (Enfit) |
| 00842071118044 | 24FR x 3.4 cm Mini ONE® Capsule Non-Balloon Button (Enfit) |
| 00842071118037 | 24FR x 2.4 cm Mini ONE® Capsule Non-Balloon Button (Enfit) |
| 00842071118020 | 24FR x 1.7 cm Mini ONE® Capsule Non-Balloon Button (Enfit) |
| 00842071118013 | 20FR x 4.4 cm Mini ONE® Capsule Non-Balloon Button (Enfit) |
| 00842071118006 | 20FR x 3.4 cm Mini ONE® Capsule Non-Balloon Button (Enfit) |
| 00842071117993 | 20FR x 2.4 cm Mini ONE® Capsule Non-Balloon Button (Enfit) |
| 00842071117986 | 20FR x 1.7 cm Mini ONE® Capsule Non-Balloon Button (Enfit) |
| 00842071117979 | 18FR x 4.4 cm Mini ONE® Capsule Non-Balloon Button (Enfit) |
| 00842071117962 | 18FR x 3.4 cm Mini ONE® Capsule Non-Balloon Button (Enfit) |
| 00842071117955 | 18FR x 3.0 cm Mini ONE® Capsule Non-Balloon Button (Enfit) |
| 00842071117948 | 18FR x 2.4 cm Mini ONE® Capsule Non-Balloon Button (Enfit) |
| 00842071117931 | 18FR x 2.0 cm Mini ONE® Capsule Non-Balloon Button (Enfit) |
| 00842071117924 | 18FR x 1.7 cm Mini ONE® Capsule Non-Balloon Button (Enfit) |
| 00842071117917 | 18FR x 1.5 cm Mini ONE® Capsule Non-Balloon Button (Enfit) |
| 00842071117900 | 18FR x 1.2 cm Mini ONE® Capsule Non-Balloon Button (Enfit) |
| 00842071117894 | 14FR x 3.0 cm Mini ONE® Capsule Non-Balloon Button (Enfit) |
| 00842071117887 | 14FR x 2.5 cm Mini ONE® Capsule Non-Balloon Button (Enfit) |
| 00842071117870 | 14FR x 2.0 cm Mini ONE® Capsule Non-Balloon Button (Enfit) |
| 00842071117863 | 14FR x 1.7 cm Mini ONE® Capsule Non-Balloon Button (Enfit) |
| 00842071117856 | 14FR x 1.5 cm Mini ONE® Capsule Non-Balloon Button (Enfit) |
| 00842071117849 | 14FR x 1.2 cm Mini ONE® Capsule Non-Balloon Button (Enfit) |
| 00842071117832 | 14FR x 1.0 cm Mini ONE® Capsule Non-Balloon Button (Enfit) |
| 00842071101145 | 24FR x 4.4 cm Mini ONE® Capsule Non-Balloon Button |
| 00842071101138 | 24FR x 3.4 cm Mini ONE® Capsule Non-Balloon Button |
| 00842071101121 | 24FR x 2.4 cm Mini ONE® Capsule Non-Balloon Button |
| 00842071101114 | 24FR x 1.7 cm Mini ONE® Capsule Non-Balloon Button |
| 00842071101107 | 20FR x 4.4 cm Mini ONE® Capsule Non-Balloon Button |
| 00842071101091 | 20FR x 3.4 cm Mini ONE® Capsule Non-Balloon Button |
| 00842071101084 | 20FR x 2.4 cm Mini ONE® Capsule Non-Balloon Button |
| 00842071101077 | 20FR x 1.7 cm Mini ONE® Capsule Non-Balloon Button |
| 00842071101053 | 18FR x 4.4 cm Mini ONE® Capsule Non-Balloon Button |
| 00842071101039 | 18FR x 3.4 cm Mini ONE® Capsule Non-Balloon Button |
| 00842071101015 | 18FR x 3.0 cm Mini ONE® Capsule Non-Balloon Button |
| 00842071100995 | 18FR x 2.4 cm Mini ONE® Capsule Non-Balloon Button |
| 00842071100971 | 18FR x 2.0 cm Mini ONE® Capsule Non-Balloon Button |
| 00842071100957 | 18FR x 1.7 cm Mini ONE® Capsule Non-Balloon Button |
| 00842071100933 | 18FR x 1.5 cm Mini ONE® Capsule Non-Balloon Button |
| 00842071100919 | 18FR x 1.2 cm Mini ONE® Capsule Non-Balloon Button |
| 00842071100896 | 14FR x 3.0 cm Mini ONE® Capsule Non-Balloon Button |
| 00842071100872 | 14FR x 2.5 cm Mini ONE® Capsule Non-Balloon Button |
| 00842071100858 | 14FR x 2.0 cm Mini ONE® Capsule Non-Balloon Button |
| 00842071100834 | 14FR x 1.7 cm Mini ONE® Capsule Non-Balloon Button |
| 00842071100810 | 14FR x 1.5 cm Mini ONE® Capsule Non-Balloon Button |
| 00842071100797 | 14FR x 1.2 cm Mini ONE® Capsule Non-Balloon Button |
| 00842071100773 | 14FR x 1.0 cm Mini ONE® Capsule 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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