Identity
- Trade Name
- STANDARD VAVD KIT FDA UDI
- Generic Name
- Cardioplegia solution administration kit FDA UDI
- Device Name
- A collection of sterile devices intended to be used to inject cardioplegia solution into the heart to interrupt its contractions during cardiopulmonary bypass surgery. It typically consists of tubing/adaptor, a filter, and a heat exchanger. This is single-use device. FDA UDI
- Model / Reference
- H-1136 FDA UDI
- Description
- A collection of sterile devices intended to be used to inject cardioplegia solution into the heart to interrupt its contractions during cardiopulmonary bypass surgery. It typically consists of tubing/adaptor, a filter, and a heat exchanger. This is single-use device. FDA UDI
Identifiers
- Catalog Number
- H-1136 FDA UDI
- Primary DI / UDI-DI
- B066H11360 FDA UDI
- 510(k) Number
- K990514 FDA UDI
- FDA Product Code
- DTP FDA UDI
- GMDN Term
- Cardioplegia solution administration kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4230 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cardioplegia solution administration kit
Standard Vavd Kit by Novosci Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
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- MPS 3 ND Delivery Set w/AA w/183 Line (16C) — QUEST MEDICAL INC · Class II
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 b75084fa-1ccc-4e18-b258-6149fefc6c3d 36 fields · synced May 30, 2026