Identity
- Trade Name
- Primado FDA UDI
- Generic Name
- Luminal device flushing tubing set, reusable FDA UDI
- Model / Reference
- PD-EZ-M FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04560224991080 FDA UDI
- FDA Product Code
- EFB FDA UDIHWE FDA UDI
- GMDN Term
- Luminal device flushing tubing set, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4200 FDA UDI878.4820 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Luminal device flushing tubing set, reusableSurgical instrument maintenance lubricant
Primado by Nakanishi Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K163483 also covers:
K202120 also covers:
- NSK Sterile Burs/Drills — NAKANISHI INC.
- NSK Sterile Burs/Drills — NAKANISHI INC.
- NSK Sterile Burs/Drills — NAKANISHI INC.
- NSK Sterile Burs/Drills — NAKANISHI INC.
- NSK Sterile Burs/Drills — NAKANISHI INC.
- NSK Sterile Burs/Drills — NAKANISHI INC.
- NSK Sterile Burs/Drills — NAKANISHI INC.
- NSK Sterile Burs/Drills — NAKANISHI INC.
- NSK Sterile Burs/Drills — NAKANISHI INC.
- NSK Sterile Burs/Drills — NAKANISHI INC.
- NSK Sterile Burs/Drills — NAKANISHI INC.
- NSK Sterile Burs/Drills — NAKANISHI INC.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nakanishi Inc.
Sources (1)
- FDA UDI b476443b-04f9-4ab8-870a-27fca829e470 33 fields · synced May 31, 2026