FDA.reportPublic FDA data

N/A

Primary DI
50885403076143
Brand
N/A
Company
CAREFUSION 2200, INC
Model
4330
Catalog number
4330
Device description
Manometer, 550 ml Three-Way Stopcock
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KRKManometer, blood-pressure, venous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRKManometer, Blood-Pressure, VenousCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20885403076142PackageGS110In Commercial Distribution
50885403076143PackageGS15In Commercial Distribution
10885403076145PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088540307614220885403076142
5088540307614350885403076143
1088540307614510885403076145

GMDN Terms#

Term, Definition table
TermDefinition
Cerebrospinal fluid manometer, line-poweredA mains electricity (AC-powered) device designed to measure the cerebrospinal fluid (CSF) pressure in a patient using an appropriate pressure/electrical transducer. It is an electronic instrument that connects with a dedicated CSF access device (catheter, cannulae, needle) inserted into the subarachnoid (intrathecal) space of the lumbar section of the spinal column; CSF pressure is typically digitally displayed on a monitor. Connectors, tubing, and CSF access devices are typically included. The device is intended to be used to determine variations in CSF pressure for the purposes of diagnosing, assessing trauma, or to evaluate some other clinical condition (e.g., tumours).

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
832696038
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
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
false
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
10351688507495MedexICU MEDICAL, INC.KRK2016-12-30
10351688507525MedexICU MEDICAL, INC.KRK2016-12-30
50351688507493MedexSMITHS MEDICAL ASD, INC.KRK2016-12-30
50351688507523MedexSMITHS MEDICAL ASD, INC.KRK2016-12-30
10885403076145N/ACAREFUSION 2200, INCKRK2016-09-23