Identity
- Trade Name
- QUICKIE PRIME - 1/4" x 1/16" FDA UDI
- Generic Name
- Cardiopulmonary bypass system priming set FDA UDI
- Device Name
- A sterile, semi-rigid tube used in open heart surgery to facilitate the transfer of priming fluids during the priming of the extracorporeal circuit of a cardiopulmonary bypass system. It is a noninvasive product in the form of a tube or tubing used to channel the fluids (i.e., primer/blood) to facilitate priming of the extracorporeal circuit and connection of the cardiopulmonary bypass system (heart/lung machine) to the patient. It is typically a moulded plastic tube with hard plastic spike at the distal end that connects to the bag or container of primer solution, a connector at the proximal end, and a central pinch clamp. This is a single-use device. FDA UDI
- Model / Reference
- 301011NS FDA UDI
- Description
- A sterile, semi-rigid tube used in open heart surgery to facilitate the transfer of priming fluids during the priming of the extracorporeal circuit of a cardiopulmonary bypass system. It is a noninvasive product in the form of a tube or tubing used to channel the fluids (i.e., primer/blood) to facilitate priming of the extracorporeal circuit and connection of the cardiopulmonary bypass system (heart/lung machine) to the patient. It is typically a moulded plastic tube with hard plastic spike at the distal end that connects to the bag or container of primer solution, a connector at the proximal end, and a central pinch clamp. This is a single-use device. FDA UDI
Identifiers
- Catalog Number
- 301011NS FDA UDI
- Primary DI / UDI-DI
- B066301011NS1 FDA UDI
- 510(k) Number
- K801402 FDA UDI
- FDA Product Code
- DTL FDA UDI
- GMDN Term
- Cardiopulmonary bypass system priming set 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: Cardiopulmonary bypass system priming set
QUICKIE PRIME - 1/4" x 1/16" by Novosci Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiopulmonary bypass system priming set.
- CENTRIMAG™ TRAINING LOOP — Thoratec Switzerland GmbH · Class II
- PEDIATRIC TRAINING LOOP — Thoratec Switzerland GmbH · Class II
- CentriMag™ — ST. JUDE MEDICAL, INC. · Class II
- QUICKIE PRIME - 32" W/2 SPIKES — NOVOSCI CORP. · Class II
- QUICKIE PRIME - 72" — NOVOSCI CORP. · Class II
- QUICKIE PRIME - 1/4" X 3/32" — NOVOSCI CORP. · Class II
- QUICKIE PRIME - 24" W/CLAMP — NOVOSCI CORP. · Class II
- QUICKIE PRIME - 1/4" X 3/32" — NOVOSCI CORP. · Class II
Cleared under the same submission
K801402 also covers:
- QUICKIE PRIME - 1/4" X 3/32" — NOVOSCI CORP.
- QUICKIE PRIME - 1/4" X 3/32" — NOVOSCI CORP.
- QUICKIE PRIME - 1/4" x 1/16" — NOVOSCI CORP.
- QUICKIE PRIME - 24" W/CLAMP — NOVOSCI CORP.
- QUICKIE PRIME - 32" W/2 SPIKES — NOVOSCI CORP.
- QUICKIE PRIME - 72" — NOVOSCI CORP.
- SPIKE, BLOOD W/ 1/4" CONNECTOR COVER — 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 42d602e8-0ce2-4195-a007-fa009d047fc6 36 fields · synced May 30, 2026