FDA.reportPublic FDA data

Fluid Management System

Primary DI
00860936000310
Brand
Fluid Management System
Company
THERMEDX, LLC
Model
P2000
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
HIGInsufflator, Hysteroscopic
HRXArthroscope
LGZWarmer, Thermal, Infusion Fluid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIGInsufflator, HysteroscopicObstetrics/Gynecology2
HRXArthroscopeOrthopedic2
LGZWarmer, Thermal, Infusion FluidGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091939000
K133799000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091939000THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000Thermedx, LLC2010-07-23HIG
K133799000THERMEDX FLUID MANAGMENT SYSTEMThermedx, LLC2014-06-20HIG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860936000310PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860936000310008609360003108609360003100860936000310

GMDN Terms#

Term, Definition table
TermDefinition
Hysteroscopic irrigation/insufflation systemA mains electricity (AC-powered) device assembly used during endoscopic procedures of the uterus (i.e., hysteroscopy) to distend (expand by pressure) the uterus by filling the uterine cavity with a liquid to improve visualization (e.g., a hysteroscope) and enlarge the surgical field; it also circulates the fluid to provide irrigation that will remove tissue/debris from the site. This system will typically electronically monitor the volume differential between the irrigation fluid flowing into and out of the uterus. Some distention systems are combined with gynaecologic resectoscopes.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
022465035
Device count
1
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860936000341High Pressure Luer Lock Set, Single Lumen 300mmHgHLL0032016-09-23
00860936000334Luer Lock Set, Single LumenLL00022016-09-23
00860936000358Tubing Set - Single Lumen, Inflow with Dual OutflowLL00042016-09-23
00860936000365Urology SetLL0006LL00062018-02-01
00860936000327Fluid Management SystemW21002016-09-23
20860936000338Luer Lock Set, Single LumenLL00022016-09-23
20860936000345High Pressure Luer Lock Set, Single Lumen 300mmHgHLL0032016-09-23
20860936000352Tubing Set - Single Lumen, Inflow with Dual OutflowLL00042016-09-23
20860936000369Urology SetLL0006LL00062018-02-01

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