FDA UDI
In Commercial Distribution
🇺🇸 United States
MiniACE Low Profile Antegrade Continence Enema Irrigation Set
DI: 00842071132170
·
Model: E2-1221-ISOSAF
·
APPLIED MEDICAL TECHNOLOGY, INC.
Product Codes
3
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- MiniACE Low Profile Antegrade Continence Enema Irrigation Set
- Primary DI
- 00842071132170
- Version / Model
- E2-1221-ISOSAF
- Catalog Number
- E2-1221-ISOSAF, 2-1221-ISOSAF
- Company Name
- APPLIED MEDICAL TECHNOLOGY, INC.
- Labeler DUNS
- 038101861
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-26
- Public Version
- 2
- Public Version Date
- 2025-04-07
- Public Version Status
- Update
- Public Device Record Key
- 0bed7c51-02e5-4882-a3c5-fcb04069ea82
Device Description
12" Right Angle Irrigation Set with ENFit® - For Use with the MiniACE® Button (Pouched), MDR
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | 876.5980 | 2 |
| EXD | Irrigator, Ostomy | Gastroenterology, Urology | 876.5895 | 2 |
| PIF | Gastrointestinal Tubes With Enteral Specific Connectors | Gastroenterology, Urology | 876.5980 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62494 | Caecostomy tube | A sterile, thin, soft, hollow tube intended to be percutaneously placed and maintained in the caecum, following caecostomy, to permit instillation of fluids for colonic irrigation and evacuation of lower bowel contents through the anus, as an aid in the management of faecal incontinence. Also known as a C-tube, it is made of synthetic polymer materials and is curled at the distal end for retention in the colon; it contains a proximal port at the caecostoma to allow flushing by the user. Disposable devices to assist tube introduction/function (e.g., cannula, drainage catheter) may be included. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00842071132217 | GS1 | Box (2-1221-ISOSAF) | 10 | In Commercial Distribution | |
| Primary | 00842071132170 | GS1 |
Customer Contacts
- Phone
- (440)717-4000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K180026 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 12 | Inch |