RUSCH 157400300

GUDID 00627843557579

Blue RUSCH branded infant manual resuscitator, oxygen reservoir tubing, swivel connector, medication port, |Peep connector and infant mask.

B.L.S. Systems Limited

Pulmonary resuscitator, manual, single-use

• Primary Device ID: 00627843557579
• NIH Device Record Key: 5673ddfd-ccb9-4a54-84e9-68fef629f20b
• Commercial Distribution Discontinuation: 2020-01-16
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: RUSCH
• Version Model Number: 157400300
• Catalog Number: 157400300
• 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: 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: 905 339 1069
• Email: tedreesor@blssystemsltd.com
• Phone: 905 339 1069
• Email: tedreesor@blssystemsltd.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00627843557579 [Primary]
GS1	10627843557576 [Package]; Package: case [6 Units]; Discontinued: 2020-01-16; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K993194

FDA Product Code

• BTM: Ventilator, Emergency, Manual (Resuscitator)

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: 2020-01-17
• Device Publish Date: 2015-08-24

On-Brand Devices [RUSCH]

• 00627843557579: Blue RUSCH branded infant manual resuscitator, oxygen reservoir tubing, swivel connector, medica
• 00627843557562: Blue RUSCH branded infant manual resuscitator, oxygen reservoir bag, swivel connector, medicatio
• 00627843557555: Blue RUSCH branded pediatric manual resuscitator, oxygen reservoir tubing, swivel connector, med
• 00627843557548: Blue RUSCH brand pediatric manual pulmonary resuscitator, oxygen reservoir bag, swivel connector
• 00627843557531: Blue RUSCH branded Adult sized manual resuscitator , oxygen reservoir bag, swivel connector, med
• 00627843557524: Blue RUSCH branded adult manual resuscitator, oxygen reservoir tubing, swivel connector, medicat