FDA.reportPublic FDA data

Infinity Trident Pod System

Primary DI
04049098051149
Brand
Infinity Trident Pod System
Company
DRAEGER MEDICAL SYSTEMS, INC.
Model
MS15007
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
KOIStimulator, Nerve, Peripheral, Electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KOIStimulator, Nerve, Peripheral, ElectricAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K042003000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042003000INFINITY TRIDENT NMT PODDraeger Medical Systems, Inc.2004-09-01KOI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049098051149PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049098051149040490980511494049098051149

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+18004372437info@draeger.com

Regulatory Flags#

DUNS number
788289952
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048675786320Infinity M540MS406362026-10-26
04049098009751Infinity M540MS263722015-10-24
04049098009799IACS w/C700MS255202015-10-24
04049098054409IACS w/C500MS255102015-10-24
04049098054454SHP UNT INFINITY M540MS204012015-10-24
04049098095778SHIP UNIT M300+MS336482025-02-19
04049098053785Infinity etCO2 SmartPod57407202015-10-24
04049098061858Disposable Mechanical Ventilation CircuitMU047712025-12-10
04049098041829Disposable Mechanical Ventilation CircuitMU047712025-12-10
04049098000406Breathing hose for Resuscitaire with AutoBreath, disposable, 25 pcs.MU108412015-10-24
04048675673408Gateway Software Server VF9.0.1MS405452025-02-19
04048675762256Gateway Software Server VF9.1.137347182025-02-19
04048675777762Gateway Software Server VF9.1.237363762025-02-19
04048675780212Infinity R50-S RecorderMS412172025-02-19
04049098001519Infinity M300 Bedside ChargerMS295582025-02-19
04049098007061Infinity Gateway USB DongleMS117002025-02-19
04049098095730Infinity M300+MS339502025-02-19
04049098096423SHP EXC M300+MS336592025-02-19
04049098099264S/W SUB VF9.0 GatewayMS400462025-02-19
04049098099608Gateway Software Server VF9.0MS400482025-02-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyKOI2026-04-15
03665023000535WiTOFIDMEDKOI2025-12-19
03665023000542WiTOFIDMEDKOI2025-12-19
03665023000559WiTOFIDMEDKOI2025-12-19
03665023000566WiTOFIDMEDKOI2025-12-19
03665023000573WiTOFIDMEDKOI2025-12-19
03665023000610WiTOFIDMEDKOI2025-12-19
04255629200751Mechanomyography Sensor (MMG) for Neuromuscular Transmission Monitor TOF3DMIPM Mammendorfer Institut für Physik und Medizin GmbHKOI2025-11-21
00860012119660iTOFNERBIO PRIVATE LIMITEDKOI2025-02-05
00850023319005TwitchView Medium ElectrodeBLINK DEVICE COMPANYKOI2024-11-07
00850023319029TwitchView™BLINK DEVICE COMPANYKOI2024-11-07
00850023319036TwitchView Small ElectrodeBLINK DEVICE COMPANYKOI2024-11-07
00850023319098TwitchView2 MonitorBLINK DEVICE COMPANYKOI2024-11-07
00850023319104TwitchView2 Charging DockBLINK DEVICE COMPANYKOI2024-11-07
00850023319111TwitchView2 Patient Cable 14'BLINK DEVICE COMPANYKOI2024-11-07
00850023319173TwitchView2 Patient Cable 20'BLINK DEVICE COMPANYKOI2024-11-07
00850023319180TwitchView Large ElectrodeBLINK DEVICE COMPANYKOI2024-11-07
07350012440268TetraHubSenzime AB (Publ.)KOI2024-10-11
07350012440237TetraGraphSenzime AB (Publ.)KOI2024-10-03
07350012440169TetraSensSenzime AB (Publ.)KOI2024-04-26
07350012440183TetraSens PediatricSenzime AB (Publ.)KOI2024-04-26
07350012440244TetraSensitiveSenzime AB (Publ.)KOI2024-04-26
07350012440176TetraSensSenzime AB (Publ.)KOI2024-04-26
07350012440190TetraSens PediatricSenzime AB (Publ.)KOI2024-04-26
07350012440251TetraSensitiveSenzime AB (Publ.)KOI2024-04-26
07350012440206TetraSensitiveSenzime AB (Publ.)KOI2023-11-06
04255629200904EPSIMEDEPSIMED LLCKOI2023-10-25
04255629200423Eye adapter TOF3DMIPM Mammendorfer Institut für Physik und Medizin GmbHKOI2023-07-10
04255629200454Thumb adapter TOF3DMIPM Mammendorfer Institut für Physik und Medizin GmbHKOI2023-07-10
04255629200393TOF3D - Neuromuscular Transmission MonitorMIPM Mammendorfer Institut für Physik und Medizin GmbHKOI2023-07-10