FDA.reportPublic FDA data

Defibtech AirAware Remote ASI Cellular Module

Primary DI
10815098020703
Brand
Defibtech AirAware Remote ASI Cellular Module
Company
DEFIBTECH, L.L.C.
Model
DCM-U1613
Published
2018-12-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
OUGMedical Device Data System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OUGMedical Device Data SystemGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10815098020703PackageGS11In Commercial Distribution
00815098020706PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081509802070310815098020703
00815098020706008150980207068150980207060815098020706

GMDN Terms#

Term, Definition table
TermDefinition
Computer network routerA device designed to steer data between the client and the serving unit, e.g., between a bedside patient monitor and a central patient monitoring unit. It may be part of a patient monitoring system.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
128340200
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815098021475Defibtech ARM XR Extended Suction Cup (package of 1)RPP-20052026-06-26
10815098020475DDU-1XX Series Adult Pads Adapter, Physio-Control ConfigurationDAC-300E2015-10-23
10815098020482DDU-1XX Series Adult Pads Adapter, Zoll ConfigurationDAC-310E2015-10-24
10815098020499DDU-1XXX/2XXX Adult Pads Adapter, Physio-Control ConfigurationDAC-20002015-10-24
10815098020505DDU-1XXX/2XXX Adult Pads Adapter, Zoll ConfigurationDAC-20102015-10-24
00815098020478DDU-1XX Series Adult Pads Adapters, Physio-ControlDAC-300E2015-10-24
00815098020485DDU-1XX Series Adult Pads Adapters, ZollDAC-310E2015-10-24
00815098020492DDU-1XXX/2XXX Series Adult Pads Adapter, Physio-ControlDAC-20002015-10-24
00815098020508DDU-1XXX/2XXX Series Adult Pad Adapters, ZollDAC-20102015-10-24
00815098021482Lifeline VIEW 2DDU-29502025-12-09
00815098021512Lifeline VIEW 2 AutoDDU-29552025-12-09
00815098021536Lifeline ECG 2DDU-29602025-12-09
00815098021550DDU-29XX series, universal pad, single pairDDP-20042025-12-09
10815098021496Lifeline VIEW 2 AED configurationDDU-29502025-12-09
10815098021526Lifeline VIEW 2 AUTO AED configurationDDU-29552025-12-09
10815098021540Lifeline ECG 2 AED configurationDDU-29602025-12-09
30815098021568Pads, DDU-29XX series, universal pad, 10 pairsDDP-20042025-12-09
50815098021579Pads, DDU-29XX series, universal pad, 40 pairsDDP-20042025-12-09
10815098020529DDU-2XXX Series ECGMA Cable, IEC ConfigurationDAC-20212015-10-24
00815098020522DDU-2XXX Series ECGMA Cable, IECDAC-20212015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048675544227Connectivity Converter CC300Drägerwerk AG & Co. KGaAOUG2026-07-17
04260658860258myoncareONCARE GmbHOUG2026-07-17
00840241600443Kestra Provided Device Patient ApplicationKestra Medical Technologies, Inc.OUG2026-07-16
00884400004871GoClinicMonitored Therapeutics, Inc.OUG2026-07-16
00884400085481GoMobileMonitored Therapeutics, Inc.OUG2026-07-16
04035479194192PatientApp 2.10.0BIOTRONIK SE & Co. KGOUG2026-07-16
00884838132337Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-07-13
00884838132344Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-07-13
04048675558552Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
04048675558569Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
04048675558576Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
04048675663997Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
00199150006038N/AMEDTRONIC, INC.OUG2026-05-23
04931921049464NANIHON KOHDEN CORPORATIONOUG2026-05-20
04931921111697NANIHON KOHDEN CORPORATIONOUG2026-05-20
00199150021277NAMEDTRONIC, INC.OUG2026-05-02
00199150042784NAMEDTRONIC, INC.OUG2026-04-30
00199874112060CliniSphereMonitored Therapeutics, Inc.OUG2026-04-28
00850022853036ProSomnus RPMO2 OSA DevicePROSOMNUS SLEEP TECHNOLOGIESOUG2026-04-24
00884838129238Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-04-17
00884838129245Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-04-17
00199150002191N/AMEDTRONIC, INC.OUG2026-04-02
05404028001158Mimics FlowMaterialise NVOUG2026-03-23
05404028001172SurgiCase OnlineMaterialise NVOUG2026-03-23
05404028001189ProPlan CMF Materialise NVOUG2026-03-23
00763000994914NAMEDTRONIC, INC.OUG2026-03-22
00382904450106BD Veritor™ InfoWiFi ModuleBECTON, DICKINSON AND COMPANYOUG2026-03-13
00884838129214Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-03-09
00884838129221Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-03-09
04035479189211PatientApp 2.9BIOTRONIK SE & Co. KGOUG2026-03-04