eudamed_udi
Primary ID: 00816085020938
NAC-PAC® RED (3.0%) (UDI 00816085020938)
Manufactured by CalibreScientific US, Inc.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for NAC-PAC® RED (3.0%) - Primary ID 00816085020938
Device Regulatory Overview
The NAC-PAC® RED (3.0%) (Model/Catalog Number: 0004303) is a medical device manufactured by CalibreScientific US, Inc.. This product is indexed under FDA Product Code / Category Classification W010499 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 0004303
- Product Code / EMDN
- W010499
- Device Name
- Digestion and Decontamination Reagents
- Database Sync Date
- 2026-08-09 17:30:38
Full Regulatory Attributes
🔒 Token Gated
{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
Unlock Compliance Data & Serialization Specs
Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.
Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of NAC-PAC® RED (3.0%)?
The registered manufacturer of record for NAC-PAC® RED (3.0%) is CalibreScientific US, Inc..
What is the Primary UDI-DI identifier for NAC-PAC® RED (3.0%)?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00816085020938.
What classification code is assigned to this device?
This device is registered under product classification code W010499.
Similar Classification Devices (W010499)
Other Devices by CalibreScientific US, Inc.
Programmatic Export
Export this master device record as standardized JSON or CSV for compliance audits.
JSON API Endpoint