DALTON OXYGEN CONCENTRATOR

GUDID 00815027012512

OXYGEN CONCENTRATOR 5 LITER.

DALTON MEDICAL CORPORATION

Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator
Primary Device ID00815027012512
NIH Device Record Keya27de8f3-8f24-47fd-b310-52d55a9ebc71
Commercial Distribution StatusIn Commercial Distribution
Brand NameDALTON OXYGEN CONCENTRATOR
Version Model NumberR-DOC5200
Company DUNS874709348
Company NameDALTON MEDICAL CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100815027012512 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CAWGenerator, Oxygen, Portable

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-30
Device Publish Date2023-03-22

On-Brand Devices [DALTON OXYGEN CONCENTRATOR]

00815027012376OXYGEN CONCENTRATOR 5 LITER.
00815027012512OXYGEN CONCENTRATOR 5 LITER.

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