gudid
Primary ID: Disposable Patient Interface
Shape-HF (UDI Disposable Patient Interface)
Manufactured by Shape Medical Systems, Inc.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Shape-HF - Primary ID Disposable Patient Interface
Device Regulatory Overview
The Shape-HF (Model/Catalog Number: Disposable Patient Interface) is a medical device manufactured by Shape Medical Systems, Inc.. This product is indexed under FDA Product Code / Category Classification BTY within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- Disposable Patient Interface
- Product Code / EMDN
- BTY
- Device Name
- Disposable Patient Interface is part of the Shape-HF testing system
- Database Sync Date
- 2026-08-09 09:43:50
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 Shape-HF?
The registered manufacturer of record for Shape-HF is Shape Medical Systems, Inc..
What is the Primary UDI-DI identifier for Shape-HF?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Disposable Patient Interface.
What classification code is assigned to this device?
This device is registered under product classification code BTY.
Similar Classification Devices (BTY)
Other Devices by Shape Medical Systems, Inc.
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