MiniACE™ ACE-1265
GUDID 00842071120016
MiniACE™ Low Profile Antegrade Continence Enema Button - 12F x 6.5cm
APPLIED MEDICAL TECHNOLOGY, INC.
Cecostomy tube Caecostomy tube Caecostomy tube Caecostomy tube Caecostomy tube Caecostomy tube Caecostomy tube Caecostomy tube Caecostomy tube Caecostomy tube Caecostomy tube Caecostomy tube Caecostomy tube Caecostomy tube Caecostomy tube| Primary Device ID | 00842071120016 |
| NIH Device Record Key | 79df03e6-51c6-473c-8ca6-968ce808145b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MiniACE™ |
| Version Model Number | ACE-1265 |
| Catalog Number | ACE-1265 |
| 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 |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00842071120016 [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 | 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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