Identity
- Trade Name
- CONNECTOR, 3/8" X 3/8" X 3/8" CLEAR PAY FDA UDI
- Generic Name
- Non-ISO80369-standardized small-bore multichannel connector, single-use FDA UDI
- Device Name
- A sterile device designed to facilitate/regulate the delivery of cardioplegic solution to the heart during a cardiopulmonary bypass procedure by connecting an administration line to a cardioplegia cannula. Also known as a cardioplegia delivery set, it basically consists of tubing [e.g., polyvinyl chloride (PVC)] with connectors. It may have a single lumen or branched multiple-lumen design and include various types of connectors, clamps, and valves, depending on additional intended uses (e.g., venting, recirculation, and/or simultaneous perfusion of vein grafts). This is a single-use device. FDA UDI
- Model / Reference
- 321333NS FDA UDI
- Description
- A sterile device designed to facilitate/regulate the delivery of cardioplegic solution to the heart during a cardiopulmonary bypass procedure by connecting an administration line to a cardioplegia cannula. Also known as a cardioplegia delivery set, it basically consists of tubing [e.g., polyvinyl chloride (PVC)] with connectors. It may have a single lumen or branched multiple-lumen design and include various types of connectors, clamps, and valves, depending on additional intended uses (e.g., venting, recirculation, and/or simultaneous perfusion of vein grafts). This is a single-use device. FDA UDI
Identifiers
- Catalog Number
- 321333NS FDA UDI
- Primary DI / UDI-DI
- B066321333NS1 FDA UDI
- 510(k) Number
- K801404 FDA UDI
- FDA Product Code
- DTL FDA UDI
- GMDN Term
- Non-ISO80369-standardized small-bore multichannel connector, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4290 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, 3/8" X 3/8" X 3/8" Clear Pay 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
K801404 also covers:
- CONNECTOR, 1/2" X 1/2" X 1/2" CLEAR PAY — NOVOSCI CORP.
- CONNECTOR, 1/2" X 1/2" X 1/4" CLEAR PAY — NOVOSCI CORP.
- CONNECTOR, 1/2" X 1/2" X 3/8" CLEAR PAY — NOVOSCI CORP.
- CONNECTOR, 1/4" X 1/2" X 1/2" CLEAR PAY — NOVOSCI CORP.
- CONNECTOR, 1/4" X 1/2'" X 1/2" CLEAR PAY — NOVOSCI CORP.
- CONNECTOR, 1/4" X 1/4" X 1/2" CLEAR PAY — NOVOSCI CORP.
- CONNECTOR, 1/4" X 1/4" X 1/4" CLEAR PAY — NOVOSCI CORP.
- CONNECTOR, 1/4" X 1/4" X 1/4" CLEAR PAY — NOVOSCI CORP.
- CONNECTOR, 1/4" X 1/4" X 3/8" CLEAR PAY — NOVOSCI CORP.
- CONNECTOR, 1/4" X 1/4" X 3/8" CLEAR PAY — NOVOSCI CORP.
- CONNECTOR, 1/4" X 3/8" X 1/4" CLEAR PAY — NOVOSCI CORP.
- CONNECTOR, 3/8" X 1/2" X 1/2" CLEAR PAY — 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 ee1484f5-6aa8-471e-8f1e-868e89575ea8 36 fields · synced May 30, 2026