GUDIDData
gudid Primary ID: AAB01

PORTRAIT AAB01 (UDI AAB01)

Manufactured by GE Healthcare Finland Oy

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for PORTRAIT AAB01 - Primary ID AAB01

Device Regulatory Overview

The PORTRAIT AAB01 (Model/Catalog Number: AAB01) is a medical device manufactured by GE Healthcare Finland Oy. This product is indexed under FDA Product Code / Category Classification DQA 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-2170-2024 View Full Alert →

CARESCAPE Canvas Smart Display, Model Numbers: a)5514418, b)5514418 / MAEP2, c)5514418-01059642, d)5514418-01080402, e)5514418-01081...

🔒 Compromised Lot & Serial Numbers Locked
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ID: Z-2171-2024 View Full Alert →

CARESCAPE B650: Model Numbers: a) MBB313, Model Numbers: 1)2095801-001, 2)2095801-001-01018416, 3)2095801-001-01023150, 4)2095801-00...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)
ID: Z-2168-2024 View Full Alert →

CARESCAPE Canvas 1000, Model Numbers: a)5865770; b)5865770-01040169; c)5865770-01054142; d)5865770-01054696; e)5865770-01054698; f)58...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)

Technical Specifications

Model Number
AAB01
Product Code / EMDN
DQA
Device Name
Portrait AAB01 SpO2 attachment accessory band, PKG of 30 PCS
Database Sync Date
2026-08-09 09:14:30

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 PORTRAIT AAB01?

The registered manufacturer of record for PORTRAIT AAB01 is GE Healthcare Finland Oy.

What is the Primary UDI-DI identifier for PORTRAIT AAB01?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is AAB01.

What classification code is assigned to this device?

This device is registered under product classification code DQA.

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