gudid
Primary ID: HM3397
B-COOL CRYO WRAP 24" W/2,2.0 PKS (UDI HM3397)
Manufactured by Hausmann Enterprises, LLC
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for B-COOL CRYO WRAP 24" W/2,2.0 PKS - Primary ID HM3397
Device Regulatory Overview
The B-COOL CRYO WRAP 24" W/2,2.0 PKS (Model/Catalog Number: HM3397) is a medical device manufactured by Hausmann Enterprises, LLC. This product is indexed under FDA Product Code / Category Classification IME within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- HM3397
- Product Code / EMDN
- IME
- Device Name
- Database Sync Date
- 2026-08-09 09:23:12
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of B-COOL CRYO WRAP 24" W/2,2.0 PKS?
The registered manufacturer of record for B-COOL CRYO WRAP 24" W/2,2.0 PKS is Hausmann Enterprises, LLC.
What is the Primary UDI-DI identifier for B-COOL CRYO WRAP 24" W/2,2.0 PKS?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is HM3397.
What classification code is assigned to this device?
This device is registered under product classification code IME.
Similar Classification Devices (IME)
Other Devices by Hausmann Enterprises, LLC
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