MiniACE ACE-1430-I
GUDID 00842071137694
MiniACE Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 3.0cm, MDR
APPLIED MEDICAL TECHNOLOGY, INC.
Caecostomy tube| Primary Device ID | 00842071137694 |
| NIH Device Record Key | 138606f1-2fdc-499e-a9a1-2032a7cc0c4e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MiniACE |
| Version Model Number | ACE-1430-I |
| Catalog Number | ACE-1430-I |
| Company DUNS | 038101861 |
| Company Name | APPLIED MEDICAL TECHNOLOGY, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | (440)717-4000 |
| cs@appliedmedical.net | |
| Phone | (440)717-4000 |
| cs@appliedmedical.net | |
| Phone | (440)717-4000 |
| cs@appliedmedical.net | |
| Phone | (440)717-4000 |
| cs@appliedmedical.net | |
| Phone | (440)717-4000 |
| cs@appliedmedical.net | |
| Phone | (440)717-4000 |
| cs@appliedmedical.net | |
| Phone | (440)717-4000 |
| cs@appliedmedical.net | |
| Phone | (440)717-4000 |
| cs@appliedmedical.net | |
| Phone | (440)717-4000 |
| cs@appliedmedical.net | |
| Phone | (440)717-4000 |
| cs@appliedmedical.net | |
| Phone | (440)717-4000 |
| cs@appliedmedical.net | |
| Phone | (440)717-4000 |
| cs@appliedmedical.net | |
| Phone | (440)717-4000 |
| cs@appliedmedical.net | |
| Phone | (440)717-4000 |
| cs@appliedmedical.net | |
| Phone | (440)717-4000 |
| cs@appliedmedical.net | |
| Phone | (440)717-4000 |
| cs@appliedmedical.net | |
| Phone | (440)717-4000 |
| cs@appliedmedical.net |
Device Dimensions
| Catheter Gauge | 14 French |
| Length | 3 Centimeter |
| Catheter Gauge | 14 French |
| Length | 3 Centimeter |
| Catheter Gauge | 14 French |
| Length | 3 Centimeter |
| Catheter Gauge | 14 French |
| Length | 3 Centimeter |
| Catheter Gauge | 14 French |
| Length | 3 Centimeter |
| Catheter Gauge | 14 French |
| Length | 3 Centimeter |
| Catheter Gauge | 14 French |
| Length | 3 Centimeter |
| Catheter Gauge | 14 French |
| Length | 3 Centimeter |
| Catheter Gauge | 14 French |
| Length | 3 Centimeter |
| Catheter Gauge | 14 French |
| Length | 3 Centimeter |
| Catheter Gauge | 14 French |
| Length | 3 Centimeter |
| Catheter Gauge | 14 French |
| Length | 3 Centimeter |
| Catheter Gauge | 14 French |
| Length | 3 Centimeter |
| Catheter Gauge | 14 French |
| Length | 3 Centimeter |
| Catheter Gauge | 14 French |
| Length | 3 Centimeter |
| Catheter Gauge | 14 French |
| Length | 3 Centimeter |
| Catheter Gauge | 14 French |
| Length | 3 Centimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00842071137694 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K180026
FDA Product Code
| KNT | Tubes, Gastrointestinal (And Accessories) |
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 | 2024-09-09 |
| Device Publish Date | 2024-08-30 |
On-Brand Devices [MiniACE]
| 00842071137892 | MiniACE Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 9.0cm, MDR |
| 00842071137885 | MiniACE Low Profile Antegrade Continence Enema Button - 14F x 9.0cm, MDR |
| 00842071137878 | MiniACE Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 8.0cm, MDR |
| 00842071137861 | MiniACE Low Profile Antegrade Continence Enema Button - 14F x 8.0cm, MDR |
| 00842071137854 | MiniACE Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 7.0cm, MDR |
| 00842071137847 | MiniACE Low Profile Antegrade Continence Enema Button - 14F x 7.0cm, MDR |
| 00842071137830 | MiniACE Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 6.5cm, MDR |
| 00842071137823 | MiniACE Low Profile Antegrade Continence Enema Button - 14F x 6.5cm, MDR |
| 00842071137816 | MiniACE Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 6.0cm, MDR |
| 00842071137809 | MiniACE Low Profile Antegrade Continence Enema Button - 14F x 6.0cm, MDR |
| 00842071137793 | MiniACE Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 5.5cm, MDR |
| 00842071137786 | MiniACE Low Profile Antegrade Continence Enema Button - 14F x 5.5cm, MDR |
| 00842071137779 | MiniACE Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 5.0cm, MDR |
| 00842071137762 | MiniACE Low Profile Antegrade Continence Enema Button - 14F x 5.0cm, MDR |
| 00842071137755 | MiniACE Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 4.4cm, MDR |
| 00842071137748 | MiniACE Low Profile Antegrade Continence Enema Button - 14F x 4.4cm, MDR |
| 00842071137731 | MiniACE Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 4.0cm, MDR |
| 00842071137724 | MiniACE Low Profile Antegrade Continence Enema Button - 14F x 4.0cm, MDR |
| 00842071137717 | MiniACE Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 3.5cm, MDR |
| 00842071137700 | MiniACE Low Profile Antegrade Continence Enema Button - 14F x 3.5cm, MDR |
| 00842071137694 | MiniACE Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 3.0cm, MDR |
| 00842071137687 | MiniACE Low Profile Antegrade Continence Enema Button - 14F x 3.0cm, MDR |
| 00842071137670 | MiniACE Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 2.7cm, MDR |
| 00842071137663 | MiniACE Low Profile Antegrade Continence Enema Button - 14F x 2.7cm, MDR |
| 00842071137656 | MiniACE Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 2.5cm, MDR |
| 00842071137649 | MiniACE Low Profile Antegrade Continence Enema Button - 14F x 2.5cm, MDR |
| 00842071137632 | MiniACE Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 2.3cm, MDR |
| 00842071137625 | MiniACE Low Profile Antegrade Continence Enema Button - 14F x 2.3cm, MDR |
| 00842071137618 | MiniACE Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 2.0cm, MDR |
| 00842071137601 | MiniACE Low Profile Antegrade Continence Enema Button - 14F x 2.0cm, MDR |
| 00842071137595 | MiniACE Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 1.7cm, MDR |
| 00842071137588 | MiniACE Low Profile Antegrade Continence Enema Button - 14F x 1.7cm, MDR |
| 00842071137571 | MiniACE Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 1.5cm, MDR |
| 00842071137564 | MiniACE Low Profile Antegrade Continence Enema Button - 14F x 1.5cm, MDR |
| 00842071137557 | MiniACE Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 1.2cm, MDR |
| 00842071137540 | MiniACE Low Profile Antegrade Continence Enema Button - 14F x 1.2cm, MDR |
| 00842071137533 | MiniACE Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 1.0cm, MDR |
| 00842071137526 | MiniACE Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 10.0cm, MDR |
| 00842071137519 | MiniACE Low Profile Antegrade Continence Enema Button - 14F x 10.0cm, MDR |
| 00842071137502 | MiniACE Low Profile Antegrade Continence Enema Button - 14F x 1.0cm, MDR |
| 00842071137496 | MiniACE Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 0.8cm, MDR |
| 00842071137489 | MiniACE Low Profile Antegrade Continence Enema Button - 14F x 0.8cm, MDR |
| 00842071137472 | MiniACE Low Profile Antegrade Continence Enema Button with Enfit® - 12F x 9.0cm, MDR |
| 00842071137465 | MiniACE Low Profile Antegrade Continence Enema Button - 12F x 9.0cm, MDR |
| 00842071137458 | MiniACE Low Profile Antegrade Continence Enema Button with Enfit® - 12F x 8.0cm, MDR |
| 00842071137441 | MiniACE Low Profile Antegrade Continence Enema Button - 12F x 8.0cm, MDR |
| 00842071137434 | MiniACE Low Profile Antegrade Continence Enema Button with Enfit® - 12F x 7.0cm, MDR |
| 00842071137427 | MiniACE Low Profile Antegrade Continence Enema Button - 12F x 7.0cm, MDR |
| 00842071137410 | MiniACE Low Profile Antegrade Continence Enema Button with Enfit® - 12F x 6.5cm, MDR |
| 00842071137403 | MiniACE Low Profile Antegrade Continence Enema Button - 12F x 6.5cm, MDR |
Trademark Results [MiniACE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MINIACE 87937732 not registered Live/Pending |
Applied Medical Technology, Inc. 2018-05-26 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.