safe t chek
Safe T Check - Safe T Check
Device Description
A collection of non-sterile devices intended to be used in conjunction with pulmonary function analysis equipment to perform a pulmonary function test. It may include a breathing mouthpiece, filter (intended to reduce contamination of parent device), and a nose clip. This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: BYP
Device Name: Mouthpiece, Breathing
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: AN
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 868.5620
Third Party Flag: N
Medical Specialty: AN
Device IdentifiersDevice Id: B279S00015
Device Type: Primary
DeviceId Issuing Agency: HIBCC
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
Device Id: B279S000151
Device Type: Unit of Use
DeviceId Issuing Agency: HIBCC
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
Device Id: B279S00012
Device Type: Package
DeviceId Issuing Agency: HIBCC
Contains DI Number: B279S00015
Package Quantity: 600
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: 2