NuFLO2 Hyperinflation System

GUDID 30641043568341

MERCURY ENTERPRISES, INC.

Pulmonary resuscitator, manual, single-use

• Primary Device ID: 30641043568341
• NIH Device Record Key: 59622e9d-a526-4b52-8e1c-8408a3121a34
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NuFLO2 Hyperinflation System
• Version Model Number: 10-56834
• Company DUNS: 032705659
• Company Name: MERCURY ENTERPRISES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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	10641043568347 [Primary]
GS1	30641043568341 [Package]; Contains: 10641043568347; 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 [NuFLO2 Hyperinflation System]

• 30641043568471: 10-56847
• 30641043568488: 10-56848
• 30641043568464: 10-56846
• 30641043568501: 10-56850
• 30641043568495: 10-56849
• 10641043568422: 10-56842
• 30641043568419: 10-56841
• 30641043568402: 10-56840
• 30641043568396: 10-56839
• 30641043568372: 10-56837
• 30641043568365: 10-56836
• 30641043568358: 10-56835
• 30641043568341: 10-56834
• 30641043568334: 10-56833
• 30641043568327: 10-56832
• 30641043568310: 10-56831
• 30641043568303: 10-56830
• 30641043568297: 10-56829
• 30641043568235: 10-56823
• 30641043568228: 10-56822
• 30641043568211: 10-56821
• 30641043568204: 10-56820
• 30641043568198: 10-56819
• 30641043568181: 10-56818
• 30641043568174: 10-56817
• 30641043568167: 10-56816
• 30641043568150: 10-56815
• 30641043568143: 10-56814
• 30641043568136: 10-56813
• 30641043568129: 10-56812
• 30641043568112: 10-56811
• 30641043568105: 10-56810
• 30641043568099: 10-56809
• 30641043568082: 10-56808
• 30641043568075: 10-56807
• 30641043568068: 10-56806
• 30641043568051: 10-56805
• 30641043568044: 10-56804
• 30641043568037: 10-56803
• 30641043568020: 10-56802
• 30641043568013: 10-56801
• 30641043568006: 10-56800
• 30641043568389: 10-56838
• 10641043568514: 10-56851