N/A

Primary DI
50885403460393
Brand
N/A
Company
CAREFUSION 2200, INC
Model
42-2323
Catalog number
42-2323
Device description
Curve Peritoneal Revision Kit 15.5 Fr x 35.5 cm
Published
2018-03-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KPMSHUNT, PERITONEAL

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170405000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170405000BD Curve Ascites ShuntCare Fusion2017-11-02KPM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885403460393PackageGS110In Commercial Distribution
10885403460395PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088540346039350885403460393
1088540346039510885403460395

GMDN Terms#

Term, Definition table
TermDefinition
Interventional radiology percutaneous-access procedure kitA collection of various sterile radiopaque instruments/devices (e.g., introducer sheath, dilator, needle, angiographic catheter) intended to be used for image-guided, single-puncture, percutaneous access to facilitate an interventional radiology procedure (e.g., bile duct biopsy, percutaneous transhepatic cholangiogram, non-vascular drainage procedures). It does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)323-9088Customer_Support@BD.com

Regulatory Flags#

DUNS number
832696038
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
10885403075995DenverCAREFUSION 2200, INCKPM2017-06-12
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