FDA UDI
In Commercial Distribution
🇺🇸 United States
AMT Mini™ Extension Set
DI: 00842071107239
·
Model: E6-2411-ISOSAF
·
APPLIED MEDICAL TECHNOLOGY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- AMT Mini™ Extension Set
- Primary DI
- 00842071107239
- Version / Model
- E6-2411-ISOSAF
- Catalog Number
- E6-2411-ISOSAF, 6-2411-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
- 2016-09-09
- Public Version
- 4
- Public Version Date
- 2023-07-14
- Public Version Status
- Update
- Public Device Record Key
- 129e694d-c766-43b6-af7b-4ce663a4baec
Device Description
24" Bolus Feeding Set with ENFit ® and Cap (Pouched)
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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62256 | Enteral tube extension | A thin, flexible tube intended for extracorporeal connection to an enteral feeding tube (e.g., nasogastric tube) to increase the length of tubing from the patient to an oral/enteral device (e.g., syringe) during enteral feeding/medication administration or aspiration. It is typically a single-lumen, rubber or plastic tube of various diameters/lengths. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00842071108335 | GS1 | Box (6-2411-ISOSAF) | 10 | In Commercial Distribution | |
| Primary | 00842071107239 | GS1 |
Customer Contacts
- Phone
- (440) 717-4000
- [email protected]
Premarket Submissions
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 24 | Inch |