Hyperinflation System

GUDID 30641043558557

MERCURY ENTERPRISES, INC.

Pulmonary resuscitator, manual, single-use

• Primary Device ID: 30641043558557
• NIH Device Record Key: 18700309-b489-44a1-bd0d-10466a6e928a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hyperinflation System
• Version Model Number: 10-55855
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (727) 573-0088
• Email: hospitalcustomerservice@mercurymed.com
• Phone: (727) 573-0088
• Email: hospitalcustomerservice@mercurymed.com
• Phone: (727) 573-0088
• Email: hospitalcustomerservice@mercurymed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10641043558553 [Primary]
GS1	30641043558557 [Package]; Contains: 10641043558553; 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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-05-19
• Device Publish Date: 2015-09-24

On-Brand Devices [Hyperinflation System]

• 30641043558694: 10-55869
• 30641043558687: 10-55868
• 10641043558676: 10-55867
• 30641043558663: 10-55866
• 30641043558649: 10-55864
• 30641043558632: 10-55863
• 30641043558625: 10-55862
• 30641043558618: 10-55861
• 30641043558601: 10-55860
• 30641043558588: 10-55858
• 30641043558571: 10-55857
• 30641043558564: 10-55856
• 30641043558557: 10-55855
• 30641043558540: 10-55854
• 30641043558533: 10-55853
• 30641043558489: 10-55848
• 30641043558472: 10-55847
• 30641043558465: 10-55846
• 30641043558458: 10-55845
• 30641043558441: 10-55844
• 30641043558434: 10-55843
• 30641043558427: 10-55842
• 30641043558410: 10-55841
• 30641043558403: 10-55840
• 30641043558397: 10-55839
• 30641043558380: 10-55838
• 30641043558373: 10-55837
• 30641043558366: 10-55836
• 30641043558359: 10-55835
• 30641043558342: 10-55834
• 30641043558335: 10-55833
• 30641043558328: 10-55832
• 30641043558311: 10-55831
• 30641043558304: 10-55830
• 30641043558298: 10-55829
• 30641043558281: 10-55828
• 30641043558274: 10-55827
• 30641043558267: 10-55826
• 30641043558243: 10-55824
• 30641043558236: 10-55823
• 30641043558229: 10-55822
• 30641043558212: 10-55821
• 30641043558205: 10-55820
• 30641043558199: 10-55819
• 30641043558182: 10-55818
• 30641043558175: 10-55817
• 30641043558168: 10-55816
• 30641043558151: 10-55815
• 30641043558144: 10-55814
• 30641043558137: 10-55813