← Back to catalogue

BiNAPS

FDA UDI

Class II (US FDA UDI)

by Salter Labs

Identity

Trade Name
BiNAPS FDA UDI
Generic Name
Respiratory apnoea monitoring system FDA UDI
Device Name
BiNAPS® SLEEP DIAGNOSTIC KIT FDA UDI
Model / Reference
5500-0-1 FDA UDI
Description
BiNAPS® SLEEP DIAGNOSTIC KIT FDA UDI

Identifiers

Catalog Number
5500-0-1 FDA UDI
Primary DI / UDI-DI
10607411301022 FDA UDI
510(k) Number
K151874 FDA UDI
FDA Product Code
BZQ FDA UDI
GMDN Term
Respiratory apnoea monitoring system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.2375 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Respiratory apnoea monitoring system

BiNAPS by Salter Labs — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Respiratory apnoea monitoring system.

Cleared under the same submission

K151874 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Salter Labs

Sources (1)

  • FDA UDI e87566f0-3b05-45e5-92d3-eb6a769fbc38 38 fields · synced May 30, 2026