Identity
- Trade Name
- CONNECTOR, EQUAL Y 3/16" FDA UDI
- Generic Name
- Non-ISO80369-standardized small-bore multichannel connector, single-use FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- C310B FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- C310B FDA UDI
- Primary DI / UDI-DI
- B066C310B1 FDA UDI
- 510(k) Number
- K821495 FDA UDI
- FDA Product Code
- KOC FDA UDI
- GMDN Term
- Non-ISO80369-standardized small-bore multichannel connector, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5820 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: Non-ISO80369-standardized small-bore multichannel connector, single-use
Connector, Equal Y 3/16" by Novosci Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Non-ISO80369-standardized small-bore multichannel connector, single-use.
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- Argyle — Cardinal Health 200, LLC · Class I
- Argyle — Cardinal Health 200, LLC · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- Argyle — Cardinalhealth · Class I
- Argyle — Cardinalhealth · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
Cleared under the same submission
K821495 also covers:
- CONNECTOR, EQUAL Y 1/2" — NOVOSCI CORP.
- CONNECTOR, EQUAL Y 1/2" W/LUER — NOVOSCI CORP.
- CONNECTOR, EQUAL Y 1/2" W/LUER — NOVOSCI CORP.
- CONNECTOR, EQUAL Y 1/4" — NOVOSCI CORP.
- CONNECTOR, EQUAL Y 1/4" — NOVOSCI CORP.
- CONNECTOR, EQUAL Y 1/4" W/LUER — NOVOSCI CORP.
- CONNECTOR, EQUAL Y 1/4" W/LUER — NOVOSCI CORP.
- CONNECTOR, EQUAL Y 3/16" — NOVOSCI CORP.
- CONNECTOR, EQUAL Y 3/8" — NOVOSCI CORP.
- CONNECTOR, EQUAL Y 3/8" — NOVOSCI CORP.
- CONNECTOR, EQUAL Y 3/8" — NOVOSCI CORP.
- CONNECTOR, EQUAL Y 3/8" W/LUER — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Novosci Corp.
Sources (1)
- FDA UDI 1796ee17-3945-4462-91fc-a33de950a615 36 fields · synced May 30, 2026