eudamed_udi
Primary ID: 00850011958308
CPAP Headgear Strap Covers (UDI 00850011958308)
Manufactured by RespiraSource, OPC
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for CPAP Headgear Strap Covers - Primary ID 00850011958308
Device Regulatory Overview
The CPAP Headgear Strap Covers (Model/Catalog Number: B07X1SRX5D) 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
- B07X1SRX5D
- Product Code / EMDN
- Z12030102
- Device Name
- CPAP Headgear Strap Covers
- Database Sync Date
- 2026-08-09 18:36:19
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 Headgear Strap Covers?
The registered manufacturer of record for CPAP Headgear Strap Covers is RespiraSource, OPC.
What is the Primary UDI-DI identifier for CPAP Headgear Strap Covers?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00850011958308.
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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