MiniACE® ACE-1027
GUDID 00842071121181
MiniACE® Low Profile Antegrade Continence Enema Button - 10F x 2.7 cm
APPLIED MEDICAL TECHNOLOGY, INC.
Cecostomy tube| Primary Device ID | 00842071121181 |
| NIH Device Record Key | bd6f5a7b-affc-431f-bcb4-9d315f091b98 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MiniACE® |
| Version Model Number | ACE-1027 |
| Catalog Number | ACE-1027 |
| 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 | 10 French |
| Length | 2.7 Centimeter |
| Catheter Gauge | 10 French |
| Length | 2.7 Centimeter |
| Catheter Gauge | 10 French |
| Length | 2.7 Centimeter |
| Catheter Gauge | 10 French |
| Length | 2.7 Centimeter |
| Catheter Gauge | 10 French |
| Length | 2.7 Centimeter |
| Catheter Gauge | 10 French |
| Length | 2.7 Centimeter |
| Catheter Gauge | 10 French |
| Length | 2.7 Centimeter |
| Catheter Gauge | 10 French |
| Length | 2.7 Centimeter |
| Catheter Gauge | 10 French |
| Length | 2.7 Centimeter |
| Catheter Gauge | 10 French |
| Length | 2.7 Centimeter |
| Catheter Gauge | 10 French |
| Length | 2.7 Centimeter |
| Catheter Gauge | 10 French |
| Length | 2.7 Centimeter |
| Catheter Gauge | 10 French |
| Length | 2.7 Centimeter |
| Catheter Gauge | 10 French |
| Length | 2.7 Centimeter |
| Catheter Gauge | 10 French |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00842071121181 [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 | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-10-21 |
| Device Publish Date | 2019-10-11 |
On-Brand Devices [MiniACE®]
| 00842071121662 | MiniACE® Low Profile Antegrade Continence Enema Button with ENFit® - 10F x 10.0 cm |
| 00842071121648 | MiniACE® Low Profile Antegrade Continence Enema Button with ENFit® - 10F x 9.0 cm |
| 00842071121624 | MiniACE® Low Profile Antegrade Continence Enema Button with ENFit® - 10F x 8.0 cm |
| 00842071121600 | MiniACE® Low Profile Antegrade Continence Enema Button with ENFit® - 10F x 7.0 cm |
| 00842071121594 | MiniACE® Low Profile Antegrade Continence Enema Button with ENFit® - 10F x 6.5 cm |
| 00842071121587 | MiniACE® Low Profile Antegrade Continence Enema Button with ENFit® - 10F x 6.0 cm |
| 00842071121570 | MiniACE® Low Profile Antegrade Continence Enema Button with ENFit® - 10F x 5.5 cm |
| 00842071121563 | MiniACE® Low Profile Antegrade Continence Enema Button with ENFit® - 10F x 5.0 cm |
| 00842071121556 | MiniACE® Low Profile Antegrade Continence Enema Button with ENFit® - 10F x 4.4 cm |
| 00842071121549 | MiniACE® Low Profile Antegrade Continence Enema Button with ENFit® - 10F x 4.0 cm |
| 00842071121532 | MiniACE® Low Profile Antegrade Continence Enema Button with ENFit® - 10F x 3.5 cm |
| 00842071121525 | MiniACE® Low Profile Antegrade Continence Enema Button with ENFit® - 10F x 3.0 cm |
| 00842071121518 | MiniACE® Low Profile Antegrade Continence Enema Button with ENFit® - 10F x 2.7 cm |
| 00842071121501 | MiniACE® Low Profile Antegrade Continence Enema Button with ENFit® - 10F x 2.5 cm |
| 00842071121495 | MiniACE® Low Profile Antegrade Continence Enema Button with ENFit® - 10F x 2.3 cm |
| 00842071121488 | MiniACE® Low Profile Antegrade Continence Enema Button with ENFit® - 10F x 2.0 cm |
| 00842071121471 | MiniACE® Low Profile Antegrade Continence Enema Button with ENFit® - 10F x 1.7 cm |
| 00842071121464 | MiniACE® Low Profile Antegrade Continence Enema Button with ENFit® - 10F x 1.5 cm |
| 00842071121457 | MiniACE® Low Profile Antegrade Continence Enema Button with ENFit® - 10F x 1.2 cm |
| 00842071121440 | MiniACE® Low Profile Antegrade Continence Enema Button with ENFit® - 10F x 1.0 cm |
| 00842071121433 | MiniACE® Low Profile Antegrade Continence Enema Button with ENFit® - 10F x 0.8 cm |
| 00842071121334 | MiniACE® Low Profile Antegrade Continence Enema Button - 10F x 10.0 cm |
| 00842071121310 | MiniACE® Low Profile Antegrade Continence Enema Button - 10F x 9.0 cm |
| 00842071121297 | MiniACE® Low Profile Antegrade Continence Enema Button - 10F x 8.0 cm |
| 00842071121273 | MiniACE® Low Profile Antegrade Continence Enema Button - 10F x 7.0 cm |
| 00842071121266 | MiniACE® Low Profile Antegrade Continence Enema Button - 10F x 6.5 cm |
| 00842071121259 | MiniACE® Low Profile Antegrade Continence Enema Button - 10F x 6.0 cm |
| 00842071121242 | MiniACE® Low Profile Antegrade Continence Enema Button - 10F x 5.5 cm |
| 00842071121235 | MiniACE® Low Profile Antegrade Continence Enema Button - 10F x 5.0 cm |
| 00842071121228 | MiniACE® Low Profile Antegrade Continence Enema Button - 10F x 4.4 cm |
| 00842071121211 | MiniACE® Low Profile Antegrade Continence Enema Button - 10F x 4.0 cm |
| 00842071121204 | MiniACE® Low Profile Antegrade Continence Enema Button - 10F x 3.5 cm |
| 00842071121198 | MiniACE® Low Profile Antegrade Continence Enema Button - 10F x 3.0 cm |
| 00842071121181 | MiniACE® Low Profile Antegrade Continence Enema Button - 10F x 2.7 cm |
| 00842071121174 | MiniACE® Low Profile Antegrade Continence Enema Button - 10F x 2.5 cm |
| 00842071121167 | MiniACE® Low Profile Antegrade Continence Enema Button - 10F x 2.3 cm |
| 00842071121150 | MiniACE® Low Profile Antegrade Continence Enema Button - 10F x 2.0 cm |
| 00842071121143 | MiniACE® Low Profile Antegrade Continence Enema Button - 10F x 1.7 cm |
| 00842071121136 | MiniACE® Low Profile Antegrade Continence Enema Button - 10F x 1.5 cm |
| 00842071121129 | MiniACE® Low Profile Antegrade Continence Enema Button - 10F x 1.2 cm |
| 00842071121112 | MiniACE® Low Profile Antegrade Continence Enema Button - 10F x 1.0 cm |
| 00842071121105 | MiniACE® Low Profile Antegrade Continence Enema Button - 10F x 0.8 cm |
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.