Disposable PEEP valve with converter 4000-PVC

GUDID B0024000PVC0

Disposable PEEP valve with converter to be used with manual resuscitators.

B.L.S. Systems Limited

PEEP valve, single-use

• Primary Device ID: B0024000PVC0
• NIH Device Record Key: 2f9714d0-ee5d-46ac-966f-f7551581b1ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable PEEP valve with converter
• Version Model Number: 4000-PVC
• Catalog Number: 4000-PVC
• Company DUNS: 200103823
• Company Name: B.L.S. Systems Limited
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 905 339 1069
• Email: tedreesor@blssystemsltd.com
• Phone: 905 339 1069
• Email: tedreesor@blssystemsltd.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B0024000PVC0 [Primary]
HIBCC	B0024000PVC2 [Package]; Package: bag [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K981415

FDA Product Code

• BYE: Attachment, Breathing, Positive End Expiratory Pressure

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: 2018-07-06
• Device Publish Date: 2017-02-13

Devices Manufactured by B.L.S. Systems Limited

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