PLV Circuit Accessories 1004968

GUDID 00606959020276

PLV Circuit Accesories, Flextube, 6" trach, 15mm taper

Respironics, Inc.

Ventilator breathing circuit, reusable

• Primary Device ID: 00606959020276
• NIH Device Record Key: 44b27869-99bd-4faf-a745-494c10154e0c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PLV Circuit Accessories
• Version Model Number: 00
• Catalog Number: 1004968
• Company DUNS: 080728314
• Company Name: Respironics, Inc.
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00606959020276 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K842876

FDA Product Code

• CBK: VENTILATOR, CONTINUOUS, FACILITY USE

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: 2019-12-11
• Device Publish Date: 2016-09-28

On-Brand Devices [PLV Circuit Accessories]

• 00606959020276: PLV Circuit Accesories, Flextube, 6" trach, 15mm taper
• 00606959020269: PLV Circuit Accessories, Mouthpiece, LC, angled, 15mm
• 00606959043220: PLV Circuit Accessory, Flextube, 2in mini, 22mm x 15mm
• 00606959043206: PLV Circuit Accessory, Flextube 5.5", 22mm x 22mm
• 00606959043008: PLV Circuit Accessories, Mouthpiece, LC, angled, 22mm