Spiro-Filter

GUDID 00855784004085

TFP Breathing Filter

Spirometrics

Breathing mouthpiece, single-use

• Primary Device ID: 00855784004085
• NIH Device Record Key: 6699d0cc-556a-4ad4-b8fc-a94da0fa2b0d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spiro-Filter
• Version Model Number: D1010
• Company DUNS: 830864406
• Company Name: Spirometrics
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855784004078 [Package]; Contains: 00855784004269; Package: box [50 Units]; In Commercial Distribution
GS1	00855784004085 [Package]; Contains: 00855784004078; Package: box [2 Units]; In Commercial Distribution
GS1	00855784004269 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K884465

FDA Product Code

• CAH: Filter, Bacterial, Breathing-Circuit

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-03-23
• Device Publish Date: 2016-10-11

Devices Manufactured by Spirometrics

• 00855784004085 - Spiro-Filter: 2020-03-23TFP Breathing Filter
• 00855784004085 - Spiro-Filter: 2020-03-23 TFP Breathing Filter
• 00855784004160 - Spirometrics: 2020-03-23 Pediatric Mouthpiece, each
• 00855784004146 - Spirometrics: 2020-03-23 Adult Mouthpiece, each
• 00855784004009 - Veinsite: 2019-01-04 Near infrared vein locator device with a liquid crystal display.
• 00855784004030 - SpiroFlow: 2018-07-06 Adult Peak Flow Meter
• 00855784004054 - SpiroFlow: 2018-07-06 Child Peak Flow Meter
• 00855784004245 - SpiroFlow: 2018-07-06 Adult Peak Flow Meter
• 00855784004191 - Spirometrics: 2018-06-11 Nose Clip, each