GUDIDData
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eudamed_udi Primary ID: 00016958060461

JAY FIT 2U (UDI 00016958060461)

Manufactured by Sunrise Medical (US) LLC

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for JAY FIT 2U - Primary ID 00016958060461

Device Regulatory Overview

The JAY FIT 2U (Model/Catalog Number: FIT 2U Back) is a medical device manufactured by Sunrise Medical (US) LLC. This product is indexed under FDA Product Code / Category Classification Y180980 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-2113-2012 View Full Alert →

Padded Swing Away Arm Rest with Receiver; Uses on wheelchair models: Quickie Q7 (EIR4), GT (EIR3), GTi (EIT4) and Zippie Zone (EIRZ1). ...

🔒 Compromised Lot & Serial Numbers Locked
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ID: Z-0453-2014 View Full Alert →

Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ14; Product is manufactured and distribut...

🔒 Compromised Lot & Serial Numbers Locked
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ID: Z-2467-2015 View Full Alert →

Quickie IRIS Wheelchair. model EIZ4-2 in combination with option code 183M02 - MONO Backrest system with Dynamic Backrest option. Provide m...

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

Technical Specifications

Model Number
FIT 2U Back
Product Code / EMDN
Y180980
Device Name
Jay Back
Database Sync Date
2026-08-09 17:44:41

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 JAY FIT 2U?

The registered manufacturer of record for JAY FIT 2U is Sunrise Medical (US) LLC.

What is the Primary UDI-DI identifier for JAY FIT 2U?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00016958060461.

What classification code is assigned to this device?

This device is registered under product classification code Y180980.

Similar Classification Devices (Y180980)

Other Devices by Sunrise Medical (US) LLC

Programmatic Export

Export this master device record as standardized JSON or CSV for compliance audits.

JSON API Endpoint