Identity
- Trade Name
- safePICO FDA UDI
- Generic Name
- Arterial blood sampling kit FDA UDI
- Device Name
- 1-Adhesive Bandage, 1-Alcohol Prep Pad, 1-Sterile Gauze Pad, 1-Bio Bag with gusset bottom, 1 safePICO 25Gx16mm (nsd) Arterial blood sampler with 23Gx16mm needle, with needle shield device (nsd) and vented TIPCAP, 1.5 mL, box of 100 pcs. FDA UDI
- Model / Reference
- 616-KIT Box of 100 FDA UDI
- Description
- 1-Adhesive Bandage, 1-Alcohol Prep Pad, 1-Sterile Gauze Pad, 1-Bio Bag with gusset bottom, 1 safePICO 25Gx16mm (nsd) Arterial blood sampler with 23Gx16mm needle, with needle shield device (nsd) and vented TIPCAP, 1.5 mL, box of 100 pcs. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 01860003561903 FDA UDI
- FDA Product Code
- JKA FDA UDIMEG FDA UDI
- GMDN Term
- Arterial blood sampling kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1675 FDA UDI880.5860 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
safePICO by Radiometer America, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Radiometer America, Inc.
Sources (1)
- FDA UDI 42191d78-dfc3-4d20-8b24-b7a33783c4d2 36 fields · synced May 31, 2026