Mini ONE® Balloon Button M1-5-2417-I
GUDID 00842071114497
24FR x 1.7cm Mini ONE® Balloon Button (Boxed Kit - ISOSAF) Low Profile Feeding Device
APPLIED MEDICAL TECHNOLOGY, INC.
Enteral feeding kit, infant| Primary Device ID | 00842071114497 |
| NIH Device Record Key | fb38c2d0-5528-4a2c-876b-685a72c40449 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Mini ONE® Balloon Button |
| Version Model Number | M1-5-2417-I |
| Catalog Number | M1-5-2417-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 |
Device Dimensions
| Length | 1.7 Centimeter |
| Length | 1.7 Centimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00842071114497 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K945618
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 | 5 |
| Public Version Date | 2019-10-07 |
| Device Publish Date | 2016-11-11 |
On-Brand Devices [Mini ONE® Balloon Button]
| 00842071119508 | 14FR x 10.0 cm Mini ONE® Balloon Button Single Pack (Box) - Low Profile Feeding Device |
| 00842071119492 | 14FR x 9.0 cm Mini ONE® Balloon Button Single Pack (Box) - Low Profile Feeding Device |
| 00842071119485 | 14FR x 8.0 cm Mini ONE® Balloon Button Single Pack (Box) - Low Profile Feeding Device |
| 00842071119478 | 14FR x 7.0 cm Mini ONE® Balloon Button Single Pack (Box) - Low Profile Feeding Device |
| 00842071119423 | 14FR x 10.0cm Mini ONE® Balloon Button (Boxed Kit - ISOSAF) Low Profile Feeding Device |
| 00842071119416 | 14FR x 9.0cm Mini ONE® Balloon Button (Boxed Kit - ISOSAF) Low Profile Feeding Device |
| 00842071119409 | 14FR x 8.0cm Mini ONE® Balloon Button (Boxed Kit - ISOSAF) Low Profile Feeding Device |
| 00842071119393 | 14FR x 7.0cm Mini ONE® Balloon Button (Boxed Kit - ISOSAF) Low Profile Feeding Device |
| 00842071119386 | 14FR x 10.0cm Mini ONE Balloon Button (Boxed Kit) Low Profile Feeding Device |
| 00842071119379 | 14FR x 9.0cm Mini ONE Balloon Button (Boxed Kit) Low Profile Feeding Device |
| 00842071119362 | 14FR x 8.0cm Mini ONE Balloon Button (Boxed Kit) Low Profile Feeding Device |
| 00842071119355 | 14FR x 7.0cm Mini ONE Balloon Button (Boxed Kit) Low Profile Feeding Device |
| 00842071114572 | 24FR x 4.4cm Mini ONE® Balloon Button (Boxed Kit - ISOSAF) Low Profile Feeding Device |
| 00842071114565 | 24FR x 4.0cm Mini ONE® Balloon Button (Boxed Kit - ISOSAF) Low Profile Feeding Device |
| 00842071114558 | 24FR x 3.5cm Mini ONE® Balloon Button (Boxed Kit - ISOSAF) Low Profile Feeding Device |
| 00842071114541 | 24FR x 3.0cm Mini ONE® Balloon Button (Boxed Kit - ISOSAF) Low Profile Feeding Device |
| 00842071114534 | 24FR x 2.7cm Mini ONE® Balloon Button (Boxed Kit - ISOSAF) Low Profile Feeding Device |
| 00842071114527 | 24FR x 2.5cm Mini ONE® Balloon Button (Boxed Kit - ISOSAF) Low Profile Feeding Device |
| 00842071114510 | 24FR x 2.3cm Mini ONE® Balloon Button (Boxed Kit - ISOSAF) Low Profile Feeding Device |
| 00842071114503 | 24FR x 2.0cm Mini ONE® Balloon Button (Boxed Kit - ISOSAF) Low Profile Feeding Device |
| 00842071114497 | 24FR x 1.7cm Mini ONE® Balloon Button (Boxed Kit - ISOSAF) Low Profile Feeding Device |
| 00842071114480 | 24FR x 1.5cm Mini ONE® Balloon Button (Boxed Kit - ISOSAF) Low Profile Feeding Device |
| 00842071114473 | 20FR x 4.4cm Mini ONE® Balloon Button (Boxed Kit - ISOSAF) Low Profile Feeding Device |
| 00842071114466 | 20FR x 4.0cm Mini ONE® Balloon Button (Boxed Kit - ISOSAF) Low Profile Feeding Device |
| 00842071114459 | 20FR x 3.5cm Mini ONE® Balloon Button (Boxed Kit - ISOSAF) Low Profile Feeding Device |
| 00842071114442 | 20FR x 3.0cm Mini ONE® Balloon Button (Boxed Kit - ISOSAF) Low Profile Feeding Device |
| 00842071114435 | 20FR x 2.7cm Mini ONE® Balloon Button (Boxed Kit - ISOSAF) Low Profile Feeding Device |
| 00842071114428 | 20FR x 2.5cm Mini ONE® Balloon Button (Boxed Kit - ISOSAF) Low Profile Feeding Device |
| 00842071114411 | 20FR x 2.3cm Mini ONE® Balloon Button (Boxed Kit - ISOSAF) Low Profile Feeding Device |
| 00842071114404 | 20FR x 2.0cm Mini ONE® Balloon Button (Boxed Kit - ISOSAF) Low Profile Feeding Device |
| 00842071114398 | 20FR x 1.7cm Mini ONE® Balloon Button (Boxed Kit - ISOSAF) Low Profile Feeding Device |
| 00842071114381 | 20FR x 1.5cm Mini ONE® Balloon Button (Boxed Kit - ISOSAF) Low Profile Feeding Device |
| 00842071114374 | 20FR x 1.2cm Mini ONE® Balloon Button (Boxed Kit - ISOSAF) Low Profile Feeding Device |
| 00842071114367 | 20FR x 1.0cm Mini ONE® Balloon Button (Boxed Kit - ISOSAF) Low Profile Feeding Device |
| 00842071114350 | 18FR x 6.0cm Mini ONE® Balloon Button (Boxed Kit - ISOSAF) Low Profile Feeding Device |
| 00842071114343 | 18FR x 5.0cm Mini ONE® Balloon Button (Boxed Kit - ISOSAF) Low Profile Feeding Device |
| 00842071114336 | 18FR x 4.4cm Mini ONE® Balloon Button (Boxed Kit - ISOSAF) Low Profile Feeding Device |
| 00842071114329 | 18FR x 4.0cm Mini ONE® Balloon Button (Boxed Kit - ISOSAF) Low Profile Feeding Device |
| 00842071114312 | 18FR x 3.5cm Mini ONE® Balloon Button (Boxed Kit - ISOSAF) Low Profile Feeding Device |
| 00842071114305 | 18FR x 3.0cm Mini ONE® Balloon Button (Boxed Kit - ISOSAF) Low Profile Feeding Device |
| 00842071114299 | 18FR x 2.7cm Mini ONE® Balloon Button (Boxed Kit - ISOSAF) Low Profile Feeding Device |
| 00842071114282 | 18FR x 2.5cm Mini ONE® Balloon Button (Boxed Kit - ISOSAF) Low Profile Feeding Device |
| 00842071114275 | 18FR x 2.3cm Mini ONE® Balloon Button (Boxed Kit - ISOSAF) Low Profile Feeding Device |
| 00842071114268 | 18FR x 2.0cm Mini ONE® Balloon Button (Boxed Kit - ISOSAF) Low Profile Feeding Device |
| 00842071114251 | 18FR x 1.7cm Mini ONE® Balloon Button (Boxed Kit - ISOSAF) Low Profile Feeding Device |
| 00842071114244 | 18FR x 1.5cm Mini ONE® Balloon Button (Boxed Kit - ISOSAF) Low Profile Feeding Device |
| 00842071114237 | 18FR x 1.2cm Mini ONE® Balloon Button (Boxed Kit - ISOSAF) Low Profile Feeding Device |
| 00842071114220 | 18FR x 1.0cm Mini ONE® Balloon Button (Boxed Kit - ISOSAF) Low Profile Feeding Device |
| 00842071114213 | 16FR x 4.4cm Mini ONE® Balloon Button (Boxed Kit - ISOSAF) Low Profile Feeding Device |
| 00842071114206 | 16FR x 4.0cm Mini ONE® Balloon Button (Boxed Kit - ISOSAF) Low Profile Feeding Device |
Trademark Results [Mini ONE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MINI ONE 77188323 3547588 Live/Registered |
Applied Medical Technology, Inc. 2007-05-23 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.