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eudamed_udi Primary ID: 00814247020185

BabyLance Safety Heelstick (UDI 00814247020185)

Manufactured by Clinical Innovations, LLC

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for BabyLance Safety Heelstick - Primary ID 00814247020185

Device Regulatory Overview

The BabyLance Safety Heelstick (Model/Catalog Number: BLN) is a medical device manufactured by Clinical Innovations, LLC. This product is indexed under FDA Product Code / Category Classification V010401 within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 3 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-1945-2026 View Full Alert →

Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery System Model/Catalog Number: VAC-6000MT Product Descrip...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
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ID: Z-0541-2021 View Full Alert →

Clinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture of Membrane Test ROM-5025, ROM-6025...

🔒 Compromised Lot & Serial Numbers Locked
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ID: Z-0123-2016 View Full Alert →

The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpartu...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
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Technical Specifications

Model Number
BLN
Product Code / EMDN
V010401
Device Name
BabyLance Safety Heelstick
Database Sync Date
2026-08-09 17:21:02

Full Regulatory Attributes

🔒 Token Gated 
{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

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Frequently Asked Questions

Who is the primary manufacturer of BabyLance Safety Heelstick?

The registered manufacturer of record for BabyLance Safety Heelstick is Clinical Innovations, LLC.

What is the Primary UDI-DI identifier for BabyLance Safety Heelstick?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00814247020185.

What classification code is assigned to this device?

This device is registered under product classification code V010401.

Similar Classification Devices (V010401)

Other Devices by Clinical Innovations, LLC

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