GUDIDData
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gudid Primary ID: 5700PE-0-1

ThermiSense (UDI 5700PE-0-1)

Manufactured by SALTER LABS

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for ThermiSense - Primary ID 5700PE-0-1

Device Regulatory Overview

The ThermiSense (Model/Catalog Number: 5700PE-0-1) is a medical device manufactured by SALTER LABS. This product is indexed under FDA Product Code / Category Classification BZQ within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 2 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-1898-2012 View Full Alert →

Adult Divided Cannula end tidal C)2 sampling w/male luer-lock connector. 7 ft, oxygen tube, 7 ft. CO2 tube RX only.For Single Patient Use ...

🔒 Compromised Lot & Serial Numbers Locked
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ID: Z-0360-2014 View Full Alert →

Salter Labs EtCO2 Sample line 15' (4.6 M) tube, male luer connectors. Rx only; Made in Mexico; Manufacturer:Salter Labs, 100 West Sycamore ...

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

Technical Specifications

Model Number
5700PE-0-1
Product Code / EMDN
BZQ
Device Name
ThermiSense Pediatric Oral/Nasal Thermal Air Flow Sensor for use with a PSG System. Reusable.
Database Sync Date
2026-08-09 09:31:02

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 ThermiSense?

The registered manufacturer of record for ThermiSense is SALTER LABS.

What is the Primary UDI-DI identifier for ThermiSense?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 5700PE-0-1.

What classification code is assigned to this device?

This device is registered under product classification code BZQ.

Similar Classification Devices (BZQ)

Other Devices by SALTER LABS

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