FDA UDI
In Commercial Distribution
🇺🇸 United States
NeoConnect Syringe-to-Syringe Coupler
DI: 00817584010567
·
Model: PCO-FNC
·
NEOMED, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- NeoConnect Syringe-to-Syringe Coupler
- Primary DI
- 00817584010567
- Version / Model
- PCO-FNC
- Catalog Number
- PCO-FNC
- Company Name
- NEOMED, INC.
- Labeler DUNS
- 799772079
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-19
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- d3f9c6e6-9854-4d42-9e16-91215b997c76
Device Description
NeoConnect Syringe-to-Syringe Coupler, Sterile Purple
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| KYX | Dispenser, Liquid Medication | General Hospital | 880.6430 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62178 | Enteral feeding/medication connector, sterile | A sterile adaptor intended to enable connection of components of an enteral feeding and/or enteral medication administration kit (e.g., connection between tubing and syringe). It is typically a small plastic device containing a lumen to facilitate enteral administration after connection; it has no additional functionality and is dedicated to enteral administration applications. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20817584010561 | GS1 | Shipper | 16 | In Commercial Distribution | |
| Package | 10817584010564 | GS1 | Case | 100 | In Commercial Distribution | |
| Primary | 00817584010567 | GS1 |
Customer Contacts
- Phone
- 886-876-2225
- [email protected]