Sapphire (UDI 1637101)
Manufactured by ICU Medical, Inc.
Device Regulatory Overview
The Sapphire (Model/Catalog Number: 1637101) is a medical device manufactured by ICU Medical, Inc.. This product is indexed under FDA Product Code / Category Classification MRZ within international Unique Device Identification (UDI) compliance databases.
Enforcement actions are currently active for this product line.
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Technical Specifications
- Model Number
- 1637101
- Product Code / EMDN
- MRZ
- Device Name
- SAPPHIRE PCA Set KVO Y-Extension, Microbore, 119 Inch
- Database Sync Date
- 2026-08-09 09:39:02
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 Sapphire?
The registered manufacturer of record for Sapphire is ICU Medical, Inc..
What is the Primary UDI-DI identifier for Sapphire?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 1637101.
What classification code is assigned to this device?
This device is registered under product classification code MRZ.
Similar Classification Devices (MRZ)
Other Devices by ICU Medical, Inc.
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