Identity
- Trade Name
- SPIKE, BLOOD W/ 1/4" CONNECTOR COVER FDA UDI
- Generic Name
- Non-ISO80369 formatted bag access spike FDA UDI
- Device Name
- A small, sterile device intended to connect an intravenous (IV) fluid bag or blood bag to a fluid line to administer fluid to a patient. It consists of a plastic hollow spike at one end intended to be inserted into the IV bag port, a connector at the other end to attach to the IV line (typically via a drip chamber) and may include an additional administration port (i.e., Y-site device). It does not include a built-in drip chamber. This is a single-use device. FDA UDI
- Model / Reference
- 301103NS FDA UDI
- Description
- A small, sterile device intended to connect an intravenous (IV) fluid bag or blood bag to a fluid line to administer fluid to a patient. It consists of a plastic hollow spike at one end intended to be inserted into the IV bag port, a connector at the other end to attach to the IV line (typically via a drip chamber) and may include an additional administration port (i.e., Y-site device). It does not include a built-in drip chamber. This is a single-use device. FDA UDI
Identifiers
- Catalog Number
- 301103NS FDA UDI
- Primary DI / UDI-DI
- B066301103NS1 FDA UDI
- 510(k) Number
- K801402 FDA UDI
- FDA Product Code
- DTL FDA UDI
- GMDN Term
- Non-ISO80369 formatted bag access spike 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 formatted bag access spike
Spike, Blood W/ 1/4" Connector Cover by Novosci Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Non-ISO80369 formatted bag access spike.
- Arisure — Yukon Medical, LLC · Class II
- ProSeal CSTD — EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED · Class II
- SPIKE ADAPTER — B. BRAUN MEDICAL INC. · Class II
- SPIKE ADAPTER — B. BRAUN MEDICAL INC. · Class II
- SPIKE ADAPTER — B. BRAUN MEDICAL INC. · Class II
- SPIKE ADAPTER — B. BRAUN MEDICAL INC. · Class II
- Arisure — Yukon Medical, LLC · Class II
- BD PhaSeal — BD Switzerland Sàrl · 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 - 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.
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 e8ee293c-e1e6-40cf-b729-817bef589439 36 fields · synced Jun 8, 2026