Device class
Class II
Regulation 862.1675
Total clearances
3
2023-08-25 → 2024-10-31
Classification details
Medical specialty
Clinical Chemistry
Regulation number
862.1675
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
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 |
| 36415 |
CPT
|
— |
Medium
|
CPT for venipuncture; collection and handling of specimen; includes supplies such as anticoagulant tubes |
| P9610 |
HCPCS
|
— |
Medium
|
HCPCS supply code for blood collection supplies and anticoagulant materials |
Pulse
Most recent 510(k) clearances