NEBULIZER BOTTLE REUSABLE 6CC; OD:18mm

GUDID 04716770324005

NEBULIZER BOTTLE REUSABLE 6CC; OD:18mm

BESMED HEALTH BUSINESS CORP.

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• Primary Device ID: 04716770324005
• NIH Device Record Key: df4898d1-eaca-47f4-a825-74c4950244b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NEBULIZER BOTTLE REUSABLE 6CC; OD:18mm
• Version Model Number: NB-32400
• Company DUNS: 658023775
• Company Name: BESMED HEALTH BUSINESS CORP.
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04716770324005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091272

FDA Product Code

• CAF: Nebulizer (Direct Patient Interface)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-12-14

Devices Manufactured by BESMED HEALTH BUSINESS CORP.

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• 04716770834238 - ICU gas sampling pack with flowmeter: 2022-08-16 OEM ref: C05096-02-11
• 04716770144306 - Straight Connector 15F/22M, 15M W/PORT & CAP: 2021-01-15
• 04716770857398 - FLOW SENSOR, ADULT: 2021-01-15
• 04716770790015 - Elbow connetor 18MM ID for nebulizer: 2020-03-23 Elbow connetor 18MM ID for nebulizer
• 04716770791043 - MOUTH PIECE (OD:18mm,22mm): 2020-03-23 MOUTH PIECE (OD:18mm,22mm)
• 04716770791081 - MOUTH PIECE(OD:22mm): 2020-03-23 MOUTH PIECE(OD:22mm)
• 04716770791098 - MOUTH PIECE (ID:18mm, OD:19.5mm): 2020-03-23 MOUTH PIECE (ID:18mm, OD:19.5mm)