Identity
- Trade Name
- Rospital Productos Medicos FDA UDI
- Generic Name
- Peripheral vascular intervention infusion catheter FDA UDI
- Device Name
- I.V. CATHETER PEN TYPE 24G X 3/4 100 EA. FDA UDI
- Model / Reference
- IVTC24 FDA UDI
- Description
- I.V. CATHETER PEN TYPE 24G X 3/4 100 EA. FDA UDI
Identifiers
- Catalog Number
- IVTC24 FDA UDI
- Primary DI / UDI-DI
- 00812460028636 FDA UDI
- 510(k) Number
- K142797 FDA UDI
- FDA Product Code
- FOZ FDA UDI
- GMDN Term
- Peripheral vascular intervention infusion catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5200 FDA UDI
- Commercial Distribution
- 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
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
No
FDA UDI
Category: Peripheral vascular intervention infusion catheter
Rospital Productos Medicos by Atlas Medical Products Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K142797 also covers:
- Rospital Productos Medicos — ATLAS MEDICAL PRODUCTS LLC
- Biotronix Healthcare IV Catheters — BIOTRONIX HEALTHCARE INDUSTRIES INC.
- Biotronix Healthcare IV Catheters — BIOTRONIX HEALTHCARE INDUSTRIES INC.
- Biotronix Healthcare IV Catheters — BIOTRONIX HEALTHCARE INDUSTRIES INC.
- Biotronix Healthcare IV Catheters — BIOTRONIX HEALTHCARE INDUSTRIES INC.
- Biotronix Healthcare IV Catheters — BIOTRONIX HEALTHCARE INDUSTRIES INC.
- I.V. Catheter — Jiang Xi Sanxin Medtec Co., Ltd.
- I.V. Catheter — Jiang Xi Sanxin Medtec Co., Ltd.
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
- Atlas Medical Products Llc
Sources (1)
- FDA UDI 3a337641-8f34-4678-922f-bda908485446 37 fields · synced Jun 8, 2026