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

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• 00840117344150 - Resp-O2 Vortex 72 Closed Suction Tracheal Catheter, 16 FR (5.3 mm),30.5 cm/12 in: 2026-01-13 T-Piece, Tracheal, Adult, STERILE-EO CONTENT: 1. Closed Suction Catheter (Adult), 1. MDI Adaptor, 1. 15 mm Swivel Adaptor, 1. 22
• 00840117344167 - Resp-O2 Vortex 72 Closed Suction Tracheal Catheter, 10 FR (3.3 mm),30.5 cm/12 in: 2026-01-13 Double Swivel Elbow (DSE), Tracheal, Adult/Pediatric CONTENTS: 1. Closed Suction Catheter (Adult/Pediatric), 1. MDI Adaptor, 1.
• 00840117344174 - Resp-O2 Vortex 72 Closed Suction Tracheal Catheter, 12 FR (4.0 mm),30.5 cm/12 in: 2026-01-13 Double Swivel Elbow (DSE), Tracheal, Adult/Pediatric CONTENTS: 1. Closed Suction Catheter (Adult/Pediatric), 1. MDI Adaptor, 1.
• 00840117344181 - Resp-O2 Vortex 72 Closed Suction Tracheal Catheter, 14 FR (4.6 mm),30.5 cm/12 in: 2026-01-13 Double Swivel Elbow (DSE), Tracheal, Adult CONTENTS: 1. Closed Suction Catheter (Adult/Pediatric), 1. MDI Adaptor, 1. 15 mm x 22