RespO2 Pediatric Manual Pulmonary Resuscitator (MPR) Mask, Reservoir Bag Oxygen

GUDID 00840117326002

Tubing, Peep Valve

DYNAREX CORPORATION

Pulmonary resuscitator, manual, single-use

• Primary Device ID: 00840117326002
• NIH Device Record Key: 38dc51d2-6dcb-477b-9c59-1ffcbe72bb55
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RespO2 Pediatric Manual Pulmonary Resuscitator (MPR) Mask, Reservoir Bag Oxygen
• Version Model Number: 36007
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• 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: false
• 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	00840117326002 [Primary]
GS1	00840117326019 [Package]; Package: Case [6 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: 2
• Public Version Date: 2024-09-20
• Device Publish Date: 2023-01-09

Devices Manufactured by DYNAREX CORPORATION

• 00840117340343 - Resp-O2 Disposable Guedel Airway, 40 mm, Newborn, Pink: 2024-12-09
• 00840117340510 - Resp-O2 Disposable Guedel Airway, 50 mm, Infant, Blue: 2024-12-09
• 00840117340527 - Resp-O2 Disposable Guedel Airway,60 mm, Toddler, Black: 2024-12-09
• 00840117340374 - Resp-O2 Disposable Guedel Airway, 70 mm, Child, White: 2024-12-09
• 00840117340381 - Resp-O2 Disposable Guedel Airway, 80 mm, Adult Small, Green: 2024-12-09
• 00840117338128 - Sharps Clean-Up Kit: 2024-11-26 Contents: Sharps Shaft, Pair of Gloves, Tweezers, BZK Towelette, Biohazard Bag, Twist Tie.
• 00810180840163 - DynaSafety Cotton-Tipped Applicators in Sealed Vial,3": 2024-11-19
• 00840117341210 - Medicine Cups 1oz: 2024-11-05