Hyperinflation

GUDID 30641043558700

MERCURY ENTERPRISES, INC.

Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use

• Primary Device ID: 30641043558700
• NIH Device Record Key: e33b7eb1-06bc-438e-ace0-6e9bd9345b92
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hyperinflation
• Version Model Number: 10-55870
• Company DUNS: 032705659
• Company Name: MERCURY ENTERPRISES, 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: 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 7275730088
• Email: hospitalcustomerservice@mercurymed.com
• Phone: 7275730088
• Email: hospitalcustomerservice@mercurymed.com
• Phone: 7275730088
• Email: hospitalcustomerservice@mercurymed.com
• Phone: 7275730088
• Email: hospitalcustomerservice@mercurymed.com
• Phone: 7275730088
• Email: hospitalcustomerservice@mercurymed.com
• Phone: 7275730088
• Email: hospitalcustomerservice@mercurymed.com
• Phone: 7275730088
• Email: hospitalcustomerservice@mercurymed.com
• Phone: 7275730088
• Email: hospitalcustomerservice@mercurymed.com
• Phone: 7275730088
• Email: hospitalcustomerservice@mercurymed.com
• Phone: 7275730088
• Email: hospitalcustomerservice@mercurymed.com
• Phone: 7275730088
• Email: hospitalcustomerservice@mercurymed.com
• Phone: 7275730088
• Email: hospitalcustomerservice@mercurymed.com
• Phone: 7275730088
• Email: hospitalcustomerservice@mercurymed.com
• Phone: 7275730088
• Email: hospitalcustomerservice@mercurymed.com
• Phone: 7275730088
• Email: hospitalcustomerservice@mercurymed.com
• Phone: 7275730088
• Email: hospitalcustomerservice@mercurymed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10641043558706 [Primary]
GS1	30641043558700 [Package]; Contains: 10641043558706; Package: [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001714

FDA Product Code

• NHK: Resuscitator, Manual, Non Self-Inflating

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: 2020-06-12
• Device Publish Date: 2020-06-04

Devices Manufactured by MERCURY ENTERPRISES, INC.

• 30641043913165 - Neo-Tee T-Piece Resuscitator Circuit: 2024-02-16
• 30641043913356 - Neo-Tee T-Piece Resuscitator Circuit: 2024-02-16
• 30641043913653 - Neo-Tee T-Piece Resuscitator Circuit: 2024-02-16
• 30641043564596 - CPR-2 Bag: 2023-07-28
• 10641043885017 - Hand Pump Assembly: 2023-06-23
• 30641043564343 - CPR-2 Bag: 2023-04-12
• 30641043566026 - CPR-2 Bag: 2023-03-17
• 30641043564572 - CPR-2 Bag: 2022-08-10