FDA.reportPublic FDA data

EM

Primary DI
00026072022429
Brand
EM
Company
Allied Medical, LLC
Model
L405
Device description
MULTILATOR
Published
2024-10-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
CCNFlowmeter, Nonback-Pressure Compensated, Bourdon Gauge

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCNFlowmeter, Nonback-Pressure Compensated, Bourdon GaugeAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00026072022429PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00026072022429000260720224290260720224290026072022429

GMDN Terms#

Term, Definition table
TermDefinition
Emergency oxygen delivery kitA portable assembly of devices designed to be used by emergency medical services (EMS) for oxygen [O2] administration to patients in first aid or emergency situations. It includes an oxygen/air breathing gas mixer, an O2 gas container, disposable rebreathing masks, and oxygen tubing. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
119066872
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00026072021439PC11-20-00112024-09-17
00026072026861ALLIED MEDICAL LLC01-90-310001-90-31002025-10-13
00026072026878ALLIED MEDICAL LLC01-90-3100-KIT01-90-3100-KIT2025-10-13
00026072026892ALLIED MEDICAL LLC01-90-392801-90-39282025-10-13
00026072026908ALLIED MEDICAL LLC01-90-3928-KIT 01-90-3928-KIT 2025-10-13
00026072001479EMLPEEP2024-05-28
00026072012161BF645502024-05-28
00026072020548BF64095-AHP2024-10-11
00026072022177EML599-0102024-05-28
00026072022184EML599-0302024-05-28
00026072022191EML599-1302024-05-28
00026072022207EML599-1402024-05-28
00026072022214EML599-1802024-05-28
00026072022238EML599-1902024-05-28
00026072022252EML599-2802024-05-28
00026072022924BF338002024-10-11
00026072022931BF338012024-05-28
00026072023006BF332072024-10-11
00026072023013BF640072024-10-11
00026072023037BF640412024-05-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00026072022436EMAllied Medical, LLCCCN2024-10-11
06977645350170SINYADanyang Xinya Valve Co., Ltd.CCN2024-08-06
16977645350177SINYADanyang Xinya Valve Co., Ltd.CCN2024-08-06
00026072022399EMAllied Medical, LLCCCN2024-05-28
00026072022405EMAllied Medical, LLCCCN2024-05-28
00026072022412EMAllied Medical, LLCCCN2024-05-28
07540200000460Amico Patient Care CorporationAmico Patient Care CorporationCCN2023-11-14
07540200000477Amico Patient Care CorporationAmico Patient Care CorporationCCN2023-11-14
07540200000484Amico Patient Care CorporationAmico Patient Care CorporationCCN2023-11-14
07540200000491Amico Patient Care CorporationAmico Patient Care CorporationCCN2023-11-14
07540200000545Amico Patient Care CorporationAmico Patient Care CorporationCCN2023-11-14
07540200000552Amico Patient Care CorporationAmico Patient Care CorporationCCN2023-11-14
07540195050051O-Two O-Two Medical Technologies IncCCN2023-11-07
07540195050075O-Two O-Two Medical Technologies IncCCN2023-11-07
00628101502768FLOWMETER, DIALOHIO MEDICAL, LLCCCN2020-09-04
00628101502775FLOWMETER, DIALOHIO MEDICAL, LLCCCN2020-09-04
00628101502782FLOWMETER, DIALOHIO MEDICAL, LLCCCN2020-09-04
00628101502799FLOWMETER, DIALOHIO MEDICAL, LLCCCN2020-09-04
00628101502805FLOWMETER, DIALOHIO MEDICAL, LLCCCN2020-09-04
00628101502812FLOWMETER, DIALOHIO MEDICAL, LLCCCN2020-09-04
00628101502829FLOWMETER, DIALOHIO MEDICAL, LLCCCN2020-09-04
00628101502690Flowmeter DialOHIO MEDICAL, LLCCCN2020-09-04
00628101502706FLOWMETER DIALOHIO MEDICAL, LLCCCN2020-09-04
00628101502713FLOWMETER DIALOHIO MEDICAL, LLCCCN2020-09-04
00628101502720FLOWMETER DIALOHIO MEDICAL, LLCCCN2020-09-04
00628101502737FLOWMETER DIALOHIO MEDICAL, LLCCCN2020-09-04
00628101502744FLOWMETER DIALOHIO MEDICAL, LLCCCN2020-09-04
00628101502751FLOWMETER DIALOHIO MEDICAL, LLCCCN2020-09-04