Chrysalis Intelligence · Product Codes · MRN

MRN · Unclassified

12 clearances · 6 unique sponsors

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Device class
—
Regulation —
Total clearances
12
2020-03-10 → 2025-01-17
Last 12 months
0
Unique sponsors
6
Classification details
Medical specialty
—
Review panel
—
Regulation number
—
Implant
—
Life-sustain / support
—
GMP exempt
—
Third-party review
—
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Mallinckrodt Manufacturing, LLC 4 0 2025-01-03
Linde Gas & Equipment, Inc. 3 0 2024-05-23
Airgas Therapeutics 2 0 2025-01-17
International Biomedical 1 0 2020-03-10
Praxair, Inc. 1 0 2020-06-19
Malinckrodt Manufacturing, LLC 1 0 2024-05-28
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.

CodeTypeDescriptionConfidenceRationale
94002 CPT — Medium Delivery of nitric oxide gas monitoring/apparatus related to anesthesia management
E1580 HCPCS Unipuncture control system for hemodialysis ✓ CMS-verified description Medium Gas delivery system equipment code
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-01-17 K242374 Airgas Therapeutics, LLC ULSPIRA TS™ Nitric Oxide Therapy System
2025-01-03 K242578 Mallinckrodt Manufacturing, LLC EVOLVE Nitric Oxide Delivery System
2024-05-28 K240410 Malinckrodt Manufacturing, LLC EVOLVE Nitric Oxide Delivery System
2024-05-23 K233251 Linde Gas & Equipment, Inc. NOxBOXi Nitric Oxide Delivery System
2023-12-06 K222930 Mallinckrodt Manufacturing, LLC Evolve Nitric Oxide Delivery System
2023-08-11 K231823 Linde Gas & Equipment, Inc. NOxBOXi Nitric Oxide Delivery System
2023-06-30 K212409 Airgas Therapeutics Ulspira TS Nitric Oxide Therapy System
2023-04-20 K211153 Mallinckrodt Manufacturing, LLC Inomax DSIR
2022-04-27 K220898 Linde Gas & Equipment, Inc. NOxBOXi Nitric Oxide Delivery System
2020-06-19 K201339 Praxair, Inc. The NOxBOXi Nitric Oxide Delivery System
2020-06-17 K200389 Mallinckrodt Manufacturing, LLC INOmax DSIR Plus
2020-03-10 K193481 International Biomedical AeroNOx 2.0 Nitric Oxide Titration & Monitoring System
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence