Resp-O2 Manual Pulmonary Resuscitator (MPR)

GUDID 00840117313941

Resp-O2 Pediatric Manual Pulmonary Resuscitator (MPR) Mask, Reservoir Tubing, Oxygen Tubing

DYNAREX CORPORATION

Pulmonary resuscitator, manual, single-use

• Primary Device ID: 00840117313941
• NIH Device Record Key: dcef199f-938c-4cb8-9948-474d16b40a96
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Resp-O2 Manual Pulmonary Resuscitator (MPR)
• Version Model Number: 36004
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	00840117313941 [Package]; Contains: 00840117313958; Package: Case [6 Units]; In Commercial Distribution
GS1	00840117313958 [Primary]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-30
• Device Publish Date: 2021-04-22

On-Brand Devices [Resp-O2 Manual Pulmonary Resuscitator (MPR)]

• 00840117313965: Resp-O2 Infant Manual Pulmonary Resuscitator (MPR) Mask, Reservoir Tubing, Oxygen Tubing
• 00840117313941: Resp-O2 Pediatric Manual Pulmonary Resuscitator (MPR) Mask, Reservoir Tubing, Oxygen Tubing
• 00840117313927: Resp-O2 Adult Manual Pulmonary Resuscitator (MPR) Mask, Reservoir Bag, Oxygen Tubing, PEEP Valve
• 00840117308404: Resp-O2 Adult Manual Pulmonary Resuscitator (MPR) Mask, Reservoir Bag, Oxygen Tubing
• 00840117308381: Resp-O2 Adult Manual Pulmonary Resuscitator Mask (MPR), Reservoir tubing, Oxygen Tubing
• 00840117308367: Resp-O2 Pediatric Manual Pulmonary Resuscitator (MPR) Mask, Reservoir Bag, Oxygen Tubing
• 00840117308343: Resp-O2 Infant Manual Pulmonary Resuscitator (MPR) Mask, Reservoir Bag, Oxygen Tubing