SINGLE USE ADULT RESUSCITATOR BALL 1600ML W/POP-OFF , 60cm H2O & MANOMETER PORT

GUDID 04716770244372

BESMED HEALTH BUSINESS CORP.

Pulmonary resuscitator, manual, single-use

• Primary Device ID: 04716770244372
• NIH Device Record Key: 13b752c8-7b8f-4858-ba66-6086e4e83a5c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SINGLE USE ADULT RESUSCITATOR BALL 1600ML W/POP-OFF , 60cm H2O & MANOMETER PORT
• Version Model Number: RE-24437
• Company DUNS: 658023775
• Company Name: BESMED HEALTH BUSINESS CORP.
• Device Count: 1
• DM Exempt: true
• 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	04716770244372 [Primary]
GS1	14716770244372 [Package]; Package: PE bag [1 Units]; In Commercial Distribution
GS1	14716770244379 [Package]; Package: carton [24 Units]; In Commercial Distribution
GS1	24716770244372 [Package]; Contains: 14716770244372; Package: carton [24 Units]; In Commercial Distribution
GS1	24716770244376 [Package]; Contains: 14716770244379; Package: carton [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021442

FDA Product Code

• BTM: Ventilator, Emergency, Manual (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: 2020-02-04
• Device Publish Date: 2016-05-23

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• 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)