Identity
- Trade Name
- STAT PROFILE FDA UDI
- Generic Name
- Assisted reproduction centrifuge tube FDA UDI
- Device Name
- Stat Profile pHOx Ultra/CCX Control CO-Ox Tri Level L7, 8 ,9 (amps) FDA UDI
- Model / Reference
- phox ultra/ccx FDA UDI
- Description
- Stat Profile pHOx Ultra/CCX Control CO-Ox Tri Level L7, 8 ,9 (amps) FDA UDI
Identifiers
- Catalog Number
- 49187 FDA UDI
- Primary DI / UDI-DI
- 00385480491877 FDA UDI
- 510(k) Number
- K110648 FDA UDI
- FDA Product Code
- JJY FDA UDI
- GMDN Term
- Assisted reproduction centrifuge tube FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Assisted reproduction centrifuge tube
Stat Profile by Nova Biomedical Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Assisted reproduction centrifuge tube.
- Sample Tube 5 mL — Vitrolife Sweden AB · Class II
- Oocyte Collection Tube 14 mL — Vitrolife Sweden AB · Class II
- Centrifuge Tube 50 mL — Vitrolife Sweden AB · Class II
- Centrifuge Tube 15 mL — Vitrolife Sweden AB · Class II
- STAT PROFILE — NOVA BIOMEDICAL CORPORATION · Class I
- STAT PROFILE — NOVA BIOMEDICAL CORPORATION · Class I
- Stat Profile — NOVA BIOMEDICAL CORPORATION · Class II
Cleared under the same submission
K110648 also covers:
- STAT PROFILE — NOVA BIOMEDICAL CORPORATION
- STAT PROFILE — NOVA BIOMEDICAL CORPORATION
- STAT PROFILE — NOVA BIOMEDICAL CORPORATION
- STAT PROFILE — NOVA BIOMEDICAL CORPORATION
- STAT PROFILE — NOVA BIOMEDICAL CORPORATION
- STAT PROFILE — NOVA BIOMEDICAL CORPORATION
- STAT PROFILE — NOVA BIOMEDICAL CORPORATION
- STAT PROFILE — NOVA BIOMEDICAL CORPORATION
- STAT PROFILE — NOVA BIOMEDICAL CORPORATION
- STAT PROFILE — NOVA BIOMEDICAL CORPORATION
- STAT PROFILE — NOVA BIOMEDICAL CORPORATION
- STAT PROFILE — NOVA BIOMEDICAL CORPORATION
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 I | Pending data |
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Manufacturer
- Manufacturer
- Nova Biomedical Corporation
Sources (1)
- FDA UDI e962d31a-3e5e-424b-9090-af3ab78bfb21 37 fields · synced Jun 8, 2026