eudamed_udi
Primary ID: 00850038100193
CPAP Mask Liners (UDI 00850038100193)
Manufactured by RespiraSource, OPC
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for CPAP Mask Liners - Primary ID 00850038100193
Device Regulatory Overview
The CPAP Mask Liners (Model/Catalog Number: B09R5STPRG) is a medical device manufactured by RespiraSource, OPC. This product is indexed under FDA Product Code / Category Classification Z12030102 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- B09R5STPRG
- Product Code / EMDN
- Z12030102
- Device Name
- CPAP Mask Liners
- Database Sync Date
- 2026-08-09 16:30:04
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 CPAP Mask Liners?
The registered manufacturer of record for CPAP Mask Liners is RespiraSource, OPC.
What is the Primary UDI-DI identifier for CPAP Mask Liners?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00850038100193.
What classification code is assigned to this device?
This device is registered under product classification code Z12030102.
Similar Classification Devices (Z12030102)
Other Devices by RespiraSource, OPC
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