FDA.reportPublic FDA data

HEMO/PICCO POD adapter, 10PIN

Primary DI
04049098009485
Brand
HEMO/PICCO POD adapter, 10PIN
Company
DRAEGER MEDICAL SYSTEMS, INC.
Model
3375958
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
DXGComputer, Diagnostic, Pre-Programmed, Single-Function

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXGComputer, Diagnostic, Pre-Programmed, Single-FunctionCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K073113000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K073113000INFINITY PICCO POD, MODEL MS16734Draeger Medical Systems, Inc.2008-01-03DXG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049098009485PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049098009485040490980094854049098009485

GMDN Terms#

Term, Definition table
TermDefinition
Patient monitoring system module, cardiac outputA small unit dedicated to the measurement of cardiac output (the volume of blood pumped by the heart per minute) obtained through a pressure transducer/catheter introduced into a blood vessel. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the cardiac output parameter/information measured and provided by this module.

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
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
04049098001878Infinity CentralStation Wide (confi)MS268002015-10-24
04049098000185Resuscitaire Birthing Room Warmer (WBR82)MU205122015-10-24
04049098000192TI500 Globetrotter Neonatal Transport SystemMU205082015-10-24
04049098000215Resuscitaire Radiant Warmer (RW82, RW82 VHA)MU205032015-10-24
04049098000413Restraint strap, replacement, carton of 10MU060112015-10-24

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Primary DI, Brand, Company table
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00885403533153ECG Slave Cable for Spaclab PCI and PC2 with PigtailBecton, Dickinson And CompanyDXG2026-09-18
00885403533160TruWave Reusable CableBecton, Dickinson And CompanyDXG2026-09-18
00885403533610TruWave Reusable CableBecton, Dickinson And CompanyDXG2026-09-18
00885403533634Pressure Slave CableBecton, Dickinson And CompanyDXG2026-09-18
00885403533641Cable COO Catheter InterfaceBecton, Dickinson And CompanyDXG2026-09-18
00885403529781ClearSightBecton, Dickinson And CompanyDXG2026-07-29
00885403529798ClearSightBecton, Dickinson And CompanyDXG2026-07-29
00885403529811ClearSightBecton, Dickinson And CompanyDXG2026-07-29
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09120073933027CNAP® Monitor 500 HDCNSystems Medizintechnik GmbHDXG2024-07-10
00850044487011Retia MedicalRETIA MEDICAL, LLCDXG2024-02-01
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