FDA.reportPublic FDA data

Denver

Primary DI
10885403075995
Brand
Denver
Company
CAREFUSION 2200, INC
Model
42-2000
Catalog number
42-2000
Device description
DENVER™ ASCITES SHUNT DOUBLE-VALVED
Published
2017-06-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KPMShunt, Peritoneal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPMShunt, PeritonealGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885403075993PackageGS15In Commercial Distribution
10885403075995PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088540307599350885403075993
1088540307599510885403075995

GMDN Terms#

Term, Definition table
TermDefinition
Peritoneovenous shuntA sterile, surgically implanted, subcutaneous plastic tube used to continuously drain ascites fluid from the peritoneal cavity to the jugular vein. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge15.5French
Device Size Text, specify0

Regulatory Flags#

DUNS number
832696038
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885403057229JamshidiBAK4508BAK45082016-09-23
10885403057236JamshidiBAK4511BAK45112016-09-23
10885403057267JamshidiBEK4511BEK45112016-09-30
10885403075971PleurX50-7000B50-7000B2017-09-15
10885403076022Denver42-301942-30192017-06-12
10885403076046Denver42-900042-90002017-06-12
10885403107702JamshidiBCTM3411SPBCTM3411SP2016-09-30
10885403108365Safe-T-CentesisPIG1260TPIG1260T2018-07-18
10885403108389Safe-T-CentesisPIG1260TSPPIG1260TSP2018-07-18
10885403108402Safe-T-CentesisPIG1280TPIG1280T2018-07-18
10885403108426Safe-T-CentesisPIG1280TSPPIG1280TSP2018-07-18
10885403108433Safe-TTPT1000SPTPT1000SP2018-07-18
10885403108488NATPT1000TPT10002018-07-18
10885403108495Safe-TTPT1000SDFTPT1000SDF2018-07-18
10885403220852NATPT1005TPT10052018-07-18
10885403220869Safe-TTPT1005SPTPT1005SP2018-07-18
10885403228131Safe-TTPT1005SDFTPT1005SDF2018-07-18
10885403231780JamshidiBAK4511DFBAK4511DF2016-09-23
10885403231896Safe-T-CentesisPIG1260TCDFPIG1260TCDF2018-07-18
10885403231902NATPT1000CDFTPT1000CDF2018-07-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860011648109Automatic Continuous Effusion Shunt (ACES) SystemPleural Dynamics, Inc.KPM2026-05-21
10885403242328N/ACAREFUSION 2200, INCKPM2018-07-26
10885403242335N/ACAREFUSION 2200, INCKPM2018-07-26
50885403242326N/ACAREFUSION 2200, INCKPM2018-07-26
50885403242333N/ACAREFUSION 2200, INCKPM2018-07-26
10885403241208CurveCAREFUSION 2200, INCKPM2018-03-16
10885403471223CurveCAREFUSION 2200, INCKPM2018-03-16
10885403471230CurveCAREFUSION 2200, INCKPM2018-03-16
50885403471221N/ACAREFUSION 2200, INCKPM2018-03-16
10885403460395N/ACAREFUSION 2200, INCKPM2018-03-14
50885403460393N/ACAREFUSION 2200, INCKPM2018-03-14
10885403076008DenverCAREFUSION 2200, INCKPM2017-06-12
10885403076015DenverCAREFUSION 2200, INCKPM2017-06-12
10885403076022DenverCAREFUSION 2200, INCKPM2017-06-12
10885403076039DenverCAREFUSION 2200, INCKPM2017-06-12
10885403076046DenverCAREFUSION 2200, INCKPM2017-06-12
10885403076060DenverCAREFUSION 2200, INCKPM2017-06-12
10885403076077DenverCAREFUSION 2200, INCKPM2017-06-12
10885403076084DenverCAREFUSION 2200, INCKPM2017-06-12
10885403219894CurveCAREFUSION 2200, INCKPM2017-06-12
10885403222672CurveCAREFUSION 2200, INCKPM2017-06-12
50885403075993DenverCAREFUSION 2200, INCKPM2017-06-12
50885403076006DenverCAREFUSION 2200, INCKPM2017-06-12
50885403076082DenverCAREFUSION 2200, INCKPM2017-06-12
50885403076013DenverCAREFUSION 2200, INCKPM2017-06-12
50885403076020DenverCAREFUSION 2200, INCKPM2017-06-12
50885403076037DenverCAREFUSION 2200, INCKPM2017-06-12
50885403076044DenverCAREFUSION 2200, INCKPM2017-06-12
50885403076068DenverCAREFUSION 2200, INCKPM2017-06-12
50885403076075DenverCAREFUSION 2200, INCKPM2017-06-12