THRESHOLD HS735EU-001

GUDID 00383730001043

Threshold PEP (735 EU) Single Unit.

RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD

Mechanical positive pressure airway secretion-clearing device Mechanical positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device

• Primary Device ID: 00383730001043
• NIH Device Record Key: 0b2d6be4-549d-42c3-b4bc-5cfa3e8c686e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: THRESHOLD
• Version Model Number: 00
• Catalog Number: HS735EU-001
• 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

Customer Support Contacts

• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00383730001043 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K961077

FDA Product Code

• BWF: SPIROMETER, THERAPEUTIC (INCENTIVE)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-11-12
• Device Publish Date: 2016-08-24

On-Brand Devices [THRESHOLD]

• 00383730001043: Threshold PEP (735 EU) Single Unit.
• 00383730001036: Threshold PEP (735), 10 pack.
• 00383730001029: Threshold IMT (730EU) Single Unit.
• 00383730001012: Threshold IMT (730), 10 pack.
• 00383730000138: Threshold Pep Assembly
• 00383730000121: Threshold IMT Assesmbly