Identity
- Trade Name
- Centesis Procedure Kit FDA UDI
- Generic Name
- Aspiration tray, single-use FDA UDI
- Device Name
- Centesis Procedure Kit 5F x 10cm Skater™ Safety Centesis Catheter with Air Lock Valve FDA UDI
- Model / Reference
- ATPK1005 FDA UDI
- Description
- Centesis Procedure Kit 5F x 10cm Skater™ Safety Centesis Catheter with Air Lock Valve FDA UDI
Identifiers
- Catalog Number
- ATPK1005 FDA UDI
- Primary DI / UDI-DI
- 00886333221004 FDA UDI
- FDA Product Code
- OJT FDA UDI
- GMDN Term
- Aspiration tray, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Centesis Procedure Kit by Argon Medical Devices, Inc. — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Argon Medical Devices, Inc.
Sources (1)
- FDA UDI 6eee049f-3829-495d-bba6-f63959a8c922 37 fields · synced Jun 9, 2026