ASTHMACHECK HS002068-010

GUDID 00383730004563

Peak Flow Meter - Pk of 10

RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD

Peak flow meter, manual Peak flow meter, manual

• Primary Device ID: 00383730004563
• NIH Device Record Key: ed54f2b8-6a3a-456f-8c6d-3755bba6cab9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASTHMACHECK
• Version Model Number: HS002068-010
• Catalog Number: HS002068-010
• Company DUNS: 220018415
• Company Name: RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD
• 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: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00383730004563 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K962924

FDA Product Code

• BZH: METER, PEAK FLOW, SPIROMETRY

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-19
• Device Publish Date: 2020-02-11

Devices Manufactured by RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD

• 00383730004648 - OVAL MOUTHPIECE: 2020-06-19 OVAL MOUTHPIECE
• 00383730004624 - PLASTIC PEDIATRIC MOUTHPIECES (715)100PK: 2020-06-17 PLASTIC PEDIATRIC MOUTHPIECES (715)100PK
• 00383730004631 - PLASTIC PEDIATRIC DISPOSABLE MOUTHPIECE: 2020-06-17 PLASTIC PEDIATRIC DISPOSABLE MOUTHPIECE
• 00383730004617 - OVAL DISPOSABLE PLASTIC MOUTHPIECE: 2020-06-15 OVAL DISPOSABLE PLASTIC MOUTHPIECE
• 00383730004495 - TBM MP Gold Chamber Assy Tested: 2020-04-01 Tidal Breathing Mode Mouthpiece Gold Chamber Assembly Tested
• 00383730004501 - I-neb Clinical Study Disc: 2020-04-01 I-neb Clinical Study Disc
• 00383730004518 - I-neb Generic ClinicalStudy Disc Power10: 2020-04-01 I-neb Generic Clinical Study Disc Power10
• 00383730004587 - I-neb In Vitro Test Disc Power 10: 2020-04-01 I-neb In Vitro Test Disc Power 10