FDA UDI
In Commercial Distribution
🇺🇸 United States
CONNECTOR, ADAPTER NEEDLE LUER
DI: B066102357NS1
·
Model: 102357NS
·
NOVOSCI CORP.
Product Codes
1
GMDN Terms
1
Identifiers
8
Pkg Device Count
500
Basic Information
- Brand Name
- CONNECTOR, ADAPTER NEEDLE LUER
- Primary DI
- B066102357NS1
- Version / Model
- 102357NS
- Catalog Number
- 102357NS
- Company Name
- NOVOSCI CORP.
- Labeler DUNS
- 938289980
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 500
- Record Status
- Published
- Publish Date
- 2016-03-07
- Public Version
- 4
- Public Version Date
- 2023-07-13
- Public Version Status
- Update
- Public Device Record Key
- d88cf532-0058-48f8-8a07-c421d16dd337
Device Description
A non-sterile device designed to connect together two or more tubes typically with the intention of creating an extension. The connecting ends of this device will typically be serrated to provide a secure grip for the applied tubes. Clips or other forms of locking devices may be applied over the tubes to further secure the fitting. This device will not be appropriate for connecting tubes that are designed to carry (withstand) high pressures [e.g., high pressure gases]. This is a single-use device.
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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | Cardiovascular | 870.4290 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64466 | Non-ISO80369-standardized small-bore linear connector, single-use | A small, non-powered, noninvasive, small-bore, tubular, two-way/linear connector with connections at each end (typically barbed, bayonet, conical, threaded and/or non-Luer-slip) which are not designed according to ISO 80369 (standard for small-bore connectors for liquids and gases) intended to connect two luminal devices (e.g., catheter, tubing, container) with each other. It may have a straight or elbow shape; it does not have a Luer connection(s) (neither lock nor slip), and does not incorporate a filter, valve, clamp, tubing nor puncturing component, and is not a dedicated gas-line connector. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B066102357NS1 | HIBCC | ||||
| Package | B066102357NS7 | HIBCC | CASE | 20000 | In Commercial Distribution | |
| Package | B066102357NS6 | HIBCC | PARTIAL CASE | 15000 | In Commercial Distribution | |
| Package | B066102357NS5 | HIBCC | PARTIAL CASE | 10000 | In Commercial Distribution | |
| Package | B066102357NS4 | HIBCC | PARTIAL CASE | 5000 | In Commercial Distribution | |
| Package | B066102357NS3 | HIBCC | PARTIAL CASE | 2500 | In Commercial Distribution | |
| Package | B066102357NS2 | HIBCC | PARTIAL CASE | 1000 | In Commercial Distribution | |
| Unit of Use | B066102357NS0 | HIBCC |
Customer Contacts
- Phone
- 800-854-0567
- [email protected]