FDA.reportPublic FDA data

N/A

Primary DI
50885403057104
Brand
N/A
Company
CAREFUSION 2200, INC
Model
4324A
Catalog number
4324A
Device description
Myelogram Tray, 22 G x 3 1/2 Inch Spinal Needle For Use with Water Soluble Contrast Media
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
MIANEEDLE, SPINAL, SHORT TERM
PWYLumbar puncture tray (adult & pediatric)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MIANeedle, Spinal, Short TermAnesthesiology2
PWYLumbar Puncture Tray (Adult & Pediatric)General Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885403057104PackageGS110In Commercial Distribution
10885403057106PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088540305710450885403057104
1088540305710610885403057106

GMDN Terms#

Term, Definition table
TermDefinition
Myelography kitA collection of sterile devices designed for injecting contrast medium into the subarachnoid (intrathecal) space (usually of the lumbar spine) for the purposes of visualizing the spinal canal by radiographic study. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

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
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
10885403242342AchieveM1411M14112017-06-12
10885403242359AchieveM1415M14152017-06-12
10885403242366AchieveM1811M18112017-06-12
10885403242373AchieveM1815M18152017-06-12
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

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Primary DI, Brand, Company table
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10197106793053CARDINAL HEALTHCardinal Health 200, LLCPWY2024-11-22
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10197106702673CARDINAL HEALTHCardinal Health 200, LLCPWY2024-08-14