Neo-Tee T-Piece Resuscitator Circuit

GUDID 30641043509054

MERCURY ENTERPRISES, INC.

Pulmonary resuscitator, manual, single-use

• Primary Device ID: 30641043509054
• NIH Device Record Key: 376c37eb-13d4-43d1-b6ec-c6a4316396a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neo-Tee T-Piece Resuscitator Circuit
• Version Model Number: 10-50905
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10641043509050 [Primary]
GS1	30641043509054 [Package]; Contains: 10641043509050; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093913

FDA Product Code

• BTL: Ventilator, Emergency, Powered (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: 2020-05-08
• Device Publish Date: 2017-12-06

On-Brand Devices [Neo-Tee T-Piece Resuscitator Circuit]

• 30641043509153: 10-50915
• 30641043509146: 10-50914
• 30641043509054: 10-50905
• 30641043509047: 10-50904
• 30641043509030: 10-50903
• 30641043509023: 10-50902
• 30641043509016: 10-50901
• 30641043509009: 10-50900
• 10641043509166: 10-50916
• 30641043913653: 10-91365
• 30641043913356: 10-91335
• 30641043913165: 10-91316