FDA UDI
In Commercial Distribution
🇺🇸 United States
AMT Y-Port Accessory
DI: 00842071113612
·
Model: E4-0005
·
APPLIED MEDICAL TECHNOLOGY, INC.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- AMT Y-Port Accessory
- Primary DI
- 00842071113612
- Version / Model
- E4-0005
- Catalog Number
- E4-0005, 4-0005
- Company Name
- APPLIED MEDICAL TECHNOLOGY, INC.
- Labeler DUNS
- 038101861
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 4c6f14b5-e0c8-4ca2-8f41-66e1d5329ac7
Device Description
Single ENFit Y-Port Accessory (Single Female Enfit to Male Enfit and Bolus Port)
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 |
|---|---|---|---|---|
| PIF | Gastrointestinal Tubes With Enteral Specific Connectors | Gastroenterology, Urology | 876.5980 | 2 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | 876.5980 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11677 | Enteral feeding kit, adult/paediatric, sterile | A collection of sterile devices that includes tubing and other materials intended to administer nutrient liquids directly into the stomach, duodenum, or jejunum of an adult or paediatric (excludes infants) patient by means of gravity or an enteral pump. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00842071113636 | GS1 | Box (4-0005) | 10 | In Commercial Distribution | |
| Primary | 00842071113612 | GS1 |
Customer Contacts
- Phone
- (440) 717-4000
- [email protected]