FDA UDI
In Commercial Distribution
🇺🇸 United States
Mini ONE® Balloon Button
DI: 00842071119782
·
Model: M1-5-12100-I
·
APPLIED MEDICAL TECHNOLOGY, INC.
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Mini ONE® Balloon Button
- Primary DI
- 00842071119782
- Version / Model
- M1-5-12100-I
- Catalog Number
- M1-5-12100-I
- Company Name
- APPLIED MEDICAL TECHNOLOGY, INC.
- Labeler DUNS
- 038101861
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-09-06
- Public Version
- 4
- Public Version Date
- 2023-07-21
- Public Version Status
- Update
- Public Device Record Key
- 3a3cb058-878e-4120-8d4a-28d395b83ec4
Device Description
12FR x 10.0 cm Mini ONE® Balloon Button (Boxed Kit - I) Low Profile Feeding Device
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Conditional
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | 876.5980 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38565 | Gastrostomy button | A sterile, short, hollow tube that is inserted into the stomach percutaneously to permit long-term enteral feeding. The tube does not permit reflux and its external end is flush with abdominal skin. This is a single-use device. | Yes | Active |
| 64461 | Enteral feeding noninvasive-component set | A collection of devices such as tubing, connectors, chambers, clamps, and bags/bottles intended to be used to create the noninvasive (i.e., fully external) portion of an enteral feeding device assembly; it is not intended for intravenous (IV) administration. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00842071119782 | GS1 |
Customer Contacts
- Phone
- (440)717-4000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K945618 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 10.0 | Centimeter | |
| Catheter Gauge | 12 | French |