FDA.reportPublic FDA data

N/A

Primary DI
50885403231832
Brand
N/A
Company
CAREFUSION 2200, INC
Model
4324ADF
Catalog number
4324ADF
Device description
Myelogram Drug Free 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
50885403231832PackageGS110In Commercial Distribution
10885403231834PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088540323183250885403231832
1088540323183410885403231834

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.

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10198956419179CARDINAL HEALTHCardinal Health 200, LLCPWY2026-03-23
10198956233539CARDINAL HEALTHCardinal Health 200, LLCPWY2026-03-02
10198956369375CARDINAL HEALTHCardinal Health 200, LLCPWY2026-02-17
10198956357976CARDINAL HEALTHCardinal Health 200, LLCPWY2026-02-13
10198956353411CARDINAL HEALTHCardinal Health 200, LLCPWY2026-02-09
10198956336674CARDINAL HEALTHCardinal Health 200, LLCPWY2026-01-22
10198956267510CARDINAL HEALTHCardinal Health 200, LLCPWY2025-12-31
10198956259034CARDINAL HEALTHCardinal Health 200, LLCPWY2025-12-11
10198956220966CARDINAL HEALTHCardinal Health 200, LLCPWY2025-10-30
10198956208520CARDINAL HEALTHCardinal Health 200, LLCPWY2025-10-13
10198956215115CARDINAL HEALTHCardinal Health 200, LLCPWY2025-10-13
10198956197312CARDINAL HEALTHCardinal Health 200, LLCPWY2025-10-01
10198956095670CARDINAL HEALTHCardinal Health 200, LLCPWY2025-07-10
10198956073760CARDINAL HEALTHCardinal Health 200, LLCPWY2025-06-13
10198956082106CARDINAL HEALTHCardinal Health 200, LLCPWY2025-05-22
10197106993941CARDINAL HEALTHCardinal Health 200, LLCPWY2025-04-18
10198956013919CARDINAL HEALTHCardinal Health 200, LLCPWY2025-04-04
10653160384335MEDLINEMEDLINE INDUSTRIES, INC.PWY2025-02-11
10653160385578MEDLINEMEDLINE INDUSTRIES, INC.PWY2025-02-11
10197106892992CARDINAL HEALTHCardinal Health 200, LLCPWY2025-01-29
10197106914151CARDINAL HEALTHCardinal Health 200, LLCPWY2025-01-28
10197106793053CARDINAL HEALTHCardinal Health 200, LLCPWY2024-11-22
10197106729212CARDINAL HEALTHCardinal Health 200, LLCPWY2024-08-23
10197106702673CARDINAL HEALTHCardinal Health 200, LLCPWY2024-08-14