EXIN

GUDID 04719871893319

Humidifier 350 ml, large Volume Nebulizer

FOREMOUNT ENTERPRISE CO., LTD.

Room humidifier

• Primary Device ID: 04719871893319
• NIH Device Record Key: 015fd171-6c44-4fb1-85a6-762d05efcf5e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXIN
• Version Model Number: MAT1563
• Company DUNS: 658718465
• Company Name: FOREMOUNT ENTERPRISE CO., LTD.
• 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: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719871893319 [Primary]

FDA Product Code

• KFZ: Humidifier, Non-Direct Patient Interface (Home-Use)

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: 2024-07-08
• Device Publish Date: 2024-06-28

On-Brand Devices [EXIN]

• 04719871894002: 30 M Corrugated Tube (22 mm,cuffed at 0.15 cm,transparent)
• 04719871893586: Two Piece Silicone Mask (PC top shell) #5
• 04719871893579: Two Piece Silicone Mask (PC top shell) #4
• 04719871893562: Two Piece Silicone Mask (PC top shell) #3
• 04719871893555: Round Silicone Mask #2
• 04719871893548: Round Silicone Mask #1
• 04719871893531: Round Silicone Mask #0
• 04719871893524: Round Silicone Mask #00
• 04719871893517: Standard cushion mask with valve #5
• 04719871893500: Standard cushion mask with valve #4
• 04719871893494: Standard cushion mask with valve #3
• 04719871893487: Standard cushion mask with valve #2
• 04719871893470: Standard cushion mask with valve #1
• 04719871893463: Standard cushion mask with valve #0
• 04719871893456: Standard cushion mask without valve #5
• 04719871893449: Standard cushion mask without valve #4
• 04719871893432: Standard cushion mask without valve #3
• 04719871893425: Standard cushion mask without valve #2
• 04719871893418: Standard cushion mask without valve #1
• 04719871893401: Standard cushion mask without valve #0
• 04719871893395: 15 mm Collapsible Tube with Swivel Elbow
• 04719871893388: HMEF, size adult
• 04719871893319: Humidifier 350 ml, large Volume Nebulizer