MiniACE™ Low Profile Antegrade Continence Enema Button ACE-1217-I
GUDID 00842071118914
MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 12F x 1.7cm
APPLIED MEDICAL TECHNOLOGY, INC.
Cecostomy tube| Primary Device ID | 00842071118914 |
| NIH Device Record Key | d60f3881-cd93-4205-801a-98a8cabb6ce9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MiniACE™ Low Profile Antegrade Continence Enema Button |
| Version Model Number | ACE-1217-I |
| Catalog Number | ACE-1217-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 | 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 | |
| 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 | 12 French |
| Catheter Gauge | 12 French |
| Length | 1.7 Centimeter |
| Catheter Gauge | 12 French |
| Length | 1.7 Centimeter |
| Catheter Gauge | 12 French |
| Length | 1.7 Centimeter |
| Catheter Gauge | 12 French |
| Length | 1.7 Centimeter |
| Catheter Gauge | 12 French |
| Length | 1.7 Centimeter |
| Catheter Gauge | 12 French |
| Length | 1.7 Centimeter |
| Catheter Gauge | 12 French |
| Length | 1.7 Centimeter |
| Catheter Gauge | 12 French |
| Length | 1.7 Centimeter |
| Catheter Gauge | 12 French |
| Length | 1.7 Centimeter |
| Catheter Gauge | 12 French |
| Length | 1.7 Centimeter |
| Catheter Gauge | 12 French |
| Length | 1.7 Centimeter |
| Catheter Gauge | 12 French |
| Length | 1.7 Centimeter |
| Catheter Gauge | 12 French |
| Length | 1.7 Centimeter |
| Catheter Gauge | 12 French |
| Length | 1.7 Centimeter |
| Catheter Gauge | 12 French |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00842071118914 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K180026
FDA Product Code
| EXD | Irrigator, Ostomy |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-10-07 |
| Device Publish Date | 2018-07-02 |
On-Brand Devices [MiniACE™ Low Profile Antegrade Continence Enema Button]
| 00842071119195 | MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 10.0cm |
| 00842071119188 | MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 9.0cm |
| 00842071119171 | MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 8.0cm |
| 00842071119164 | MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 7.0cm |
| 00842071119157 | MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 6.5cm |
| 00842071119140 | MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 6.0cm |
| 00842071119133 | MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 5.5cm |
| 00842071119126 | MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 5.0cm |
| 00842071119119 | MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 4.4cm |
| 00842071119102 | MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 4.0cm |
| 00842071119096 | MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 3.5cm |
| 00842071119089 | MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 3.0cm |
| 00842071119072 | MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 2.7cm |
| 00842071119065 | MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 2.5cm |
| 00842071119058 | MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 2.3cm |
| 00842071119041 | MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 2.0cm |
| 00842071119034 | MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 1.7cm |
| 00842071119027 | MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 1.5cm |
| 00842071119010 | MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 1.2cm |
| 00842071119003 | MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 1.0cm |
| 00842071118990 | MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 0.8cm |
| 00842071118983 | MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 12F x 4.0cm |
| 00842071118976 | MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 12F x 3.5cm |
| 00842071118969 | MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 12F x 3.0cm |
| 00842071118952 | MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 12F x 2.7cm |
| 00842071118945 | MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 12F x 2.5cm |
| 00842071118938 | MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 12F x 2.3cm |
| 00842071118921 | MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 12F x 2.0cm |
| 00842071118914 | MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 12F x 1.7cm |
| 00842071118907 | MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 12F x 1.5cm |
| 00842071118891 | MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 12F x 1.2cm |
| 00842071118884 | MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 12F x 1.0cm |
| 00842071118877 | MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 12F x 0.8cm |
| 00842071118860 | MiniACE™ Low Profile Antegrade Continence Enema Button - 14F x 10.0cm |
| 00842071118853 | MiniACE™ Low Profile Antegrade Continence Enema Button - 14F x 9.0cm |
| 00842071118846 | MiniACE™ Low Profile Antegrade Continence Enema Button - 14F x 8.0cm |
| 00842071118839 | MiniACE™ Low Profile Antegrade Continence Enema Button - 14F x 7.0cm |
| 00842071118822 | MiniACE™ Low Profile Antegrade Continence Enema Button - 14F x 6.5cm |
| 00842071118815 | MiniACE™ Low Profile Antegrade Continence Enema Button - 14F x 6.0cm |
| 00842071118808 | MiniACE™ Low Profile Antegrade Continence Enema Button - 14F x 5.5cm |
| 00842071118792 | MiniACE™ Low Profile Antegrade Continence Enema Button - 14F x 5.0cm |
| 00842071118785 | MiniACE™ Low Profile Antegrade Continence Enema Button - 14F x 4.4cm |
| 00842071118778 | MiniACE™ Low Profile Antegrade Continence Enema Button - 14F x 4.0cm |
| 00842071118761 | MiniACE™ Low Profile Antegrade Continence Enema Button - 14F x 3.5cm |
| 00842071118754 | MiniACE™ Low Profile Antegrade Continence Enema Button - 14F x 3.0cm |
| 00842071118747 | MiniACE™ Low Profile Antegrade Continence Enema Button - 14F x 2.7cm |
| 00842071118730 | MiniACE™ Low Profile Antegrade Continence Enema Button - 14F x 2.5cm |
| 00842071118723 | MiniACE™ Low Profile Antegrade Continence Enema Button - 14F x 2.3cm |
| 00842071118716 | MiniACE™ Low Profile Antegrade Continence Enema Button - 14F x 2.0cm |
| 00842071118709 | MiniACE™ Low Profile Antegrade Continence Enema Button - 14F x 1.7cm |
Trademark Results [MiniACE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MINIACE 87937732 not registered Live/Pending |
Applied Medical Technology, Inc. 2018-05-26 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.