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.

00850027043791 - Precision Medical2026-03-05 HOLDER,ENDO TUBE,PMI (10/BX),DISPOSABLE
00850027043807 - Precision Medical2026-03-05 GUARD,TRACHEOTOMY TUBE,DISPOSABLE
00850027043821 - Precision Medical Inc.2026-03-05 CANISTER,SUCTION 2000CC
00850027043838 - Precision Medical Inc.2026-03-05 CANISTER,SUCTION,2000CC,PKG/12
00850027043845 - Precision Medical Inc.2026-03-05 FLOW SELECTOR
00850027043852 - Precision Medical Inc.2026-03-05 REGULATOR ASSY,AIR,HARRIS,CGA950 X DISS M
00850027043814 - Precision Medical2026-01-13 PM3600 SERIES,HF CONT VAC REG ,POLE CL,CALDERA MED
00850027043692 - Precision Medical2025-07-24 PMX3300 SERIES,VAC REG,INTERMITTENT,200MMHG,DIGITAL

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