Resp-O2 Compressor Nebulizer Plus

GUDID 00840117308831

DYNAREX CORPORATION

Nebulizing system, non-heated Nebulizing system, non-heated Nebulizing system, non-heated Nebulizing system, non-heated Nebulizing system, non-heated Nebulizing system, non-heated Nebulizing system, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated

Primary Device ID	00840117308831
NIH Device Record Key	8c7bc1d0-85dc-4375-862e-78844f5f6d20
Commercial Distribution Status	In Commercial Distribution
Brand Name	Resp-O2 Compressor Nebulizer Plus
Version Model Number	34407
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	false
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	false
RX Perscription	false
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840117308831 [Primary]
GS1	00840117308848 [Package] Package: Case [6 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K091272

FDA Product Code

CAF	Nebulizer (Direct Patient Interface)

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	2022-05-19
Device Publish Date	2022-05-11

On-Brand Devices [Resp-O2 Compressor Nebulizer Plus]

00616784561837	Resp-O2 Compressor Nebulizer Plus; Contains 6ml Nebulizer bottle, adult mask, child mask, 7ft tu
00840117308831	34407