ICU gas sampling pack with flowmeter

GUDID 04716770834238

OEM ref: C05096-02-11

BESMED HEALTH BUSINESS CORP.

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• Primary Device ID: 04716770834238
• NIH Device Record Key: f8e6d9e4-8a5c-41cf-bb18-21c9d1834bc5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ICU gas sampling pack with flowmeter
• Version Model Number: OT-83423
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04716770834238 [Primary]

FDA Product Code

• CCK: Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

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: 2022-08-16
• Device Publish Date: 2022-08-08

Devices Manufactured by BESMED HEALTH BUSINESS CORP.

• 04716770834221 - ICU gas sampling pack: 2022-08-16 OEM ref: C05096-01-11
• 04716770834238 - ICU gas sampling pack with flowmeter: 2022-08-16OEM ref: C05096-02-11
• 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)