LARYNGOSCOPE

GUDID 04719872102007

A hand-held disposable device intended to be used by anaesthesia/emergency service personnel to manipulate the tongue, preventing it from obstructing the oropharynx and enabling a clear view of the trachea for the insertion of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation.

ENTER MEDICAL CORPORATION

Rigid intubation laryngoscope, single-use

• Primary Device ID: 04719872102007
• NIH Device Record Key: 471b2454-5569-4e31-acd0-d1c0afbd379b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LARYNGOSCOPE
• Version Model Number: ENT-2002
• Company DUNS: 658833116
• Company Name: ENTER MEDICAL CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719872102007 [Primary]

FDA Product Code

• CCW: Laryngoscope, Rigid

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: 2023-06-27
• Device Publish Date: 2023-06-19

Devices Manufactured by ENTER MEDICAL CORPORATION

• 04719872100607 - RESERVOIR: 2023-10-27 RESERVOIR
• 04719872101208 - Seal Rite Mask: 2023-10-27 Seal Rite Mask
• 04719872102021 - Catheter Mount: 2023-10-27 Catheter Mount
• 04719872103028 - Bubble Humidifier: 2023-10-27 Bubble Humidifier
• 04719872104414 - Nasal Cannula: 2023-10-27 Nasal Cannula
• 04719872104568 - reusable resuscitator: 2023-10-27 reusable resuscitator
• 04719872109631 - Disposable Resuscitator: 2023-10-27 Disposable Resuscitator
• 04719872109853 - Anaesthetic Face Mask: 2023-10-27 Anaesthetic Face Mask