MiniACE™ ACE-1265-I
GUDID 00842071120108
MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 12F x 6.5cm
APPLIED MEDICAL TECHNOLOGY, INC.
Cecostomy tube| Primary Device ID | 00842071120108 |
| NIH Device Record Key | 82678f64-25bd-40d4-b655-ea174d1815ae |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MiniACE™ |
| Version Model Number | ACE-1265-I |
| Catalog Number | ACE-1265-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
| Length | 6.5 Centimeter |
| Catheter Gauge | 12 French |
| Length | 6.5 Centimeter |
| Catheter Gauge | 12 French |
| Length | 6.5 Centimeter |
| Catheter Gauge | 12 French |
| Length | 6.5 Centimeter |
| Catheter Gauge | 12 French |
| Length | 6.5 Centimeter |
| Catheter Gauge | 12 French |
| Length | 6.5 Centimeter |
| Catheter Gauge | 12 French |
| Length | 6.5 Centimeter |
| Catheter Gauge | 12 French |
| Length | 6.5 Centimeter |
| Catheter Gauge | 12 French |
| Length | 6.5 Centimeter |
| Catheter Gauge | 12 French |
| Length | 6.5 Centimeter |
| Catheter Gauge | 12 French |
| Length | 6.5 Centimeter |
| Catheter Gauge | 12 French |
| Length | 6.5 Centimeter |
| Catheter Gauge | 12 French |
| Length | 6.5 Centimeter |
| Catheter Gauge | 12 French |
| Length | 6.5 Centimeter |
| Catheter Gauge | 12 French |
| Length | 6.5 Centimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00842071120108 [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 | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-10-07 |
| Device Publish Date | 2019-09-06 |
On-Brand Devices [MiniACE™]
| 00842071120146 | MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 12F x 10.0cm |
| 00842071120139 | MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 12F x 9.0cm |
| 00842071120122 | MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 12F x 8.0cm |
| 00842071120115 | MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 12F x 7.0cm |
| 00842071120108 | MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 12F x 6.5cm |
| 00842071120092 | MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 12F x 6.0cm |
| 00842071120085 | MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 12F x 5.5cm |
| 00842071120078 | MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 12F x 5.0cm |
| 00842071120061 | MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 12F x 4.4cm |
| 00842071120054 | MiniACE™ Low Profile Antegrade Continence Enema Button - 12F x 10.0cm |
| 00842071120047 | MiniACE™ Low Profile Antegrade Continence Enema Button - 12F x 9.0cm |
| 00842071120030 | MiniACE™ Low Profile Antegrade Continence Enema Button - 12F x 8.0cm |
| 00842071120023 | MiniACE™ Low Profile Antegrade Continence Enema Button - 12F x 7.0cm |
| 00842071120016 | MiniACE™ Low Profile Antegrade Continence Enema Button - 12F x 6.5cm |
| 00842071120009 | MiniACE™ Low Profile Antegrade Continence Enema Button - 12F x 6.0cm |
| 00842071119997 | MiniACE™ Low Profile Antegrade Continence Enema Button - 12F x 5.5cm |
| 00842071119980 | MiniACE™ Low Profile Antegrade Continence Enema Button - 12F x 5.0cm |
| 00842071119973 | MiniACE™ Low Profile Antegrade Continence Enema Button - 12F x 4.4cm |
Trademark Results [MiniACE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MINIACE 87937732 not registered Live/Pending |
Applied Medical Technology, Inc. 2018-05-26 |
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