gudid
Primary ID: B602L
Leakbuster (UDI B602L)
Manufactured by Pretium Canada Packaging ULC
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Leakbuster - Primary ID B602L
Device Regulatory Overview
The Leakbuster (Model/Catalog Number: B602L) is a medical device manufactured by Pretium Canada Packaging ULC. This product is indexed under FDA Product Code / Category Classification FMH within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- B602L
- Product Code / EMDN
- FMH
- Device Name
- Specimen Container, 60 ml, Sterile, Magenta Lined Cap.
- Database Sync Date
- 2026-08-09 09:14:13
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 Leakbuster?
The registered manufacturer of record for Leakbuster is Pretium Canada Packaging ULC.
What is the Primary UDI-DI identifier for Leakbuster?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is B602L.
What classification code is assigned to this device?
This device is registered under product classification code FMH.
Similar Classification Devices (FMH)
Other Devices by Pretium Canada Packaging ULC
Programmatic Export
Export this master device record as standardized JSON or CSV for compliance audits.
JSON API Endpoint