FDA UDI
In Commercial Distribution
🇺🇸 United States
CONNECTOR, STRAIGHT 3/8" X 3/8" W/LUER NO CAP
DI: B066C135E1
·
Model: C135E
·
NOVOSCI CORP.
Product Codes
1
GMDN Terms
1
Identifiers
6
Pkg Device Count
200
Basic Information
- Brand Name
- CONNECTOR, STRAIGHT 3/8" X 3/8" W/LUER NO CAP
- Primary DI
- B066C135E1
- Version / Model
- C135E
- Catalog Number
- C135E
- Company Name
- NOVOSCI CORP.
- Labeler DUNS
- 938289980
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 200
- Record Status
- Published
- Publish Date
- 2015-10-13
- Public Version
- 4
- Public Version Date
- 2023-07-11
- Public Version Status
- Update
- Public Device Record Key
- 08ea95e6-83ec-4b5e-87b2-e623044c7fe9
Device Description
A plastic device designed to join two or more tubes of a cardiopulmonary bypass system circuit, typically to create an extension or shunt; it may also be used to connect ancillary disposable devices (e.g., temperature probe). It typically has a Y-shape or straight design and is profiled at its ends to create leak-proof connections. 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
- No
- 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 |
|---|---|---|---|---|
| KOC | Accessories, Blood Circuit, Hemodialysis | Gastroenterology, Urology | 876.5820 | 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 |
|---|---|---|---|---|---|---|
| Package | B066C135E5 | HIBCC | CASE | 1000 | In Commercial Distribution | |
| Primary | B066C135E1 | HIBCC | ||||
| Package | B066C135E4 | HIBCC | PARTIAL CASE | 800 | In Commercial Distribution | |
| Package | B066C135E3 | HIBCC | PARTIAL CASE | 600 | In Commercial Distribution | |
| Package | B066C135E2 | HIBCC | PARTIAL CASE | 400 | In Commercial Distribution | |
| Unit of Use | B066C135E0 | HIBCC |
Customer Contacts
- Phone
- 800-854-0567
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K821495 | 000 |