Device class
Class II
Regulation 880.2800
Total clearances
5
2020-03-13 → 2024-04-05
Definition
What is A Chemical Vapor Sterilization Multivariable Chemical Indicator
A chemical vapor sterilization multivariable chemical indicator monitors two or more parameters of a chemical vapor sterilization process.
Classification details
Medical specialty
General Hospital
Regulation number
880.2800
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 |
| A4399 |
HCPCS
|
Ostomy irrigation supply; cone/catheter, with or without brush ✓ CMS-verified description |
Medium
|
Sterilization chemical indicator supply; covers multivariable chemical vapor indicators |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2024-04-05 |
K232103 |
Terragene S.A.
|
Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40) |
| 2022-04-20 |
K212022 |
3M Company
|
3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E |
| 2022-01-07 |
K213262 |
STERIS Corporation
|
CELERITY HP Chemical Indicator |
| 2020-12-07 |
K203284 |
3M Company
|
3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator |
| 2020-03-13 |
K193110 |
3M Healthcare
|
3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E |