Identity
- Trade Name
- CONNECTOR, 3/16" X 3/16" W/OUT PART LINE W/LUER FDA UDI
- Generic Name
- Luer/non-ISO80369-standardized linear connector, single-use FDA UDI
- Device Name
- A sterile 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. FDA UDI
- Model / Reference
- 332011NS FDA UDI
- Description
- A sterile 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. FDA UDI
Identifiers
- Catalog Number
- 332011NS FDA UDI
- Primary DI / UDI-DI
- B066332011NS1 FDA UDI
- 510(k) Number
- K802542 FDA UDI
- FDA Product Code
- KRI FDA UDI
- GMDN Term
- Luer/non-ISO80369-standardized linear connector, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 870.4200 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ethylene Oxide FDA UDI
Category: Luer/non-ISO80369-standardized linear connector, single-use
Connector, 3/16" X 3/16" W/Out Part Line W/Luer by Novosci Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Luer/non-ISO80369-standardized linear connector, single-use.
- BD PhaSeal — BECTON DICKINSON PEN LIMITED · Class II
- Cook — COOK INCORPORATED · Class I
- Cook — COOK INCORPORATED · Class I
- BD PhaSeal Optima — BD Switzerland Sàrl · Class II
- Cook — COOK INCORPORATED · Class I
- COOK — COOK INCORPORATED · Class II
- BD PhaSeal™ Optima — BD Switzerland Sàrl · Class II
- Cook — COOK INCORPORATED · Class I
Cleared under the same submission
K802542 also covers:
- CONNECTOR, 1/2" X 1/2" W/LUER — NOVOSCI CORP.
- CONNECTOR, 1/2" X 1/2" W/OUT PART LINE W/LUER — NOVOSCI CORP.
- CONNECTOR, 1/4" X 1/2" W/OUT PART LINE — NOVOSCI CORP.
- CONNECTOR, 1/4" X 1/4" W/LUER — NOVOSCI CORP.
- CONNECTOR, 1/4" X 1/4" W/OUT PART LINE — NOVOSCI CORP.
- CONNECTOR, 1/4" X 1/4" W/OUT PART LINE — NOVOSCI CORP.
- CONNECTOR, 1/4" X 1/4" W/OUT PART LINE W/LUER — NOVOSCI CORP.
- CONNECTOR, 1/4" X 3/8" W/O PART LINE W/LUER — NOVOSCI CORP.
- CONNECTOR, 1/4" X 3/8" W/OUT PART LINE — NOVOSCI CORP.
- CONNECTOR, 1/4" X 3/8" W/OUT PART LINE — NOVOSCI CORP.
- CONNECTOR, 3/16" X 1/4" W/OUT PART LINE — NOVOSCI CORP.
- CONNECTOR, 3/16" X 1/4" W/OUT PART LINE — NOVOSCI CORP.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Novosci Corp.
Sources (1)
- FDA UDI 2fb22e4c-1a4c-4676-b744-a0605f6571f8 36 fields · synced May 31, 2026