Primary Sets (UDI B947301)
Manufactured by ICU Medical, Inc.
Device Regulatory Overview
The Primary Sets (Model/Catalog Number: B947301) is a medical device manufactured by ICU Medical, Inc.. This product is indexed under FDA Product Code / Category Classification FPA 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
- B947301
- Product Code / EMDN
- FPA
- Device Name
- Primary MICRODRIP Set 2 CLAVE Y-Sites, 100 Inch, Non-DEHP
- 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 Primary Sets?
The registered manufacturer of record for Primary Sets is ICU Medical, Inc..
What is the Primary UDI-DI identifier for Primary Sets?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is B947301.
What classification code is assigned to this device?
This device is registered under product classification code FPA.
Similar Classification Devices (FPA)
Other Devices by ICU Medical, Inc.
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