Precision Medical Inc. \ Luxfer

GUDID 00855887006689

1901-76501,PM4150 SERIES,CONCENTRATOR,OXYGEN,PORTABLE, 5 LITER Manufactured by Precision Medical Inc. for Luxfer

Precision Medical, Inc.

Portable oxygen concentrator
Primary Device ID00855887006689
NIH Device Record Key758b0eb2-347a-4e90-bf32-ce46fbfd312d
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrecision Medical Inc. \ Luxfer
Version Model Number1901-76501
Company DUNS112569116
Company NamePrecision Medical, Inc.
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100855887006689 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-05-18

Devices Manufactured by Precision Medical, Inc.

00850027043746 - Precision Medical2024-12-20 1900 SERIES,REG,O2,EP5,HOMEFILL,NON-CE
00850027043739 - Precision Medical2024-11-21 Filtered Vacuum Regulator Trap
00855887006993 - Precision Medical Inc.2024-10-01 PM5900,MONITOR,O2, DRW
00850027043494 - Precision Medical2024-05-21 PMX3000 SERIES,VAC REG,CONT,2POSN,200MMHG
00850027043500 - Precision Medical2024-05-21 PMX3100 SERIES,VAC REG,CONT,3POSN,200MMHG
00850027043517 - Precision Medical2024-05-21 PMX3300 SERIES,VAC REG,INTERMITTENT,200MMHG
00850027043524 - Precision Medical2024-05-21 PMX3400 SERIES,VAC REG,INTERMITTENT,150MMHG
00850027043531 - Precision Medical2024-05-21 PMX3500 SERIES,VAC REG,CONT,2POSN,150MMHG

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.