Device class
Class II
Regulation 880.5725
Total clearances
3
2020-07-02 → 2024-03-15
Definition
What is Peripheral Intravenous (Piv) Infiltration Monitor
Peripheral catheter monitor (PIV) indicated for the detection of subcutaneous infiltrations and extravasations.
Classification details
Medical specialty
General Hospital
Regulation number
880.5725
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Ivwatch, LLC
|
3 |
0 |
2024-03-15 |
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| 36035 |
CPT
|
— |
Medium
|
Peripheral IV placement; infiltration monitoring adjunctive to IV management |
| A4649 |
HCPCS
|
Surgical supply; miscellaneous ✓ CMS-verified description |
Medium
|
Peritoneal dialysis catheter/infusion supplies; infiltration monitoring device as supply component |
Pulse
Most recent 510(k) clearances