FDA.reportPublic FDA data

Medichoice

Primary DI
50885632114845
Brand
Medichoice
Company
OWENS & MINOR DISTRIBUTION, INC.
Model
LPT648
Device description
X Rx Tray Lumbar Puncture With Manometer Latex-Free Sterile MediChoice
Published
2016-08-20
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

Product Codes#

Code, Name table
CodeName
FMJMANOMETER, SPINAL-FLUID

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMJManometer, Spinal-FluidGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885632114845PackageGS110In Commercial Distribution
10885632114847PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088563211484550885632114845
1088563211484710885632114847

GMDN Terms#

Term, Definition table
TermDefinition
Lumbar puncture kitA collection of devices intended for transient percutaneous access to the subarachnoid (intrathecal) or epidural space of the lumbar spinal column to obtain a sample of cerebrospinal fluid (CSF). Typical components include a spinal needle and collection tubes for the CSF; a drainage catheter is not included. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature68 Degrees Fahrenheit77 Degrees Fahrenheit
Special Storage Condition, Specify00
Special Storage Condition, Specify00Avoid Freezing and Excessive Heat

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
007941230
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
true
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
10885632522819SurgiTrackSM450087976F2026-06-08
10885632506000HalyardNADSG2012026-06-05
10885632506017HalyardNADSG2022026-06-05
10885632506024HalyardNADSG2032026-06-05
10885632522642SurgiTrackSM45013041502026-06-05
10885632522659SurgiTrackSM4501306C1C2026-06-05
10885632522543SurgiTrackSM450030A7E12026-06-04
10885632522512SurgiTrackSM45004591012026-06-03
10885632522222SurgiTrackSM45005945A12026-06-01
10885632522109SurgiTrackSM4501306C092026-05-29
10885632522079SurgiTrackSM450045D71A2026-05-28
10885632434266Halyard563482026-05-22
10885632434303Halyard563522026-05-22
10885632468490Halyard614862026-05-22
10885632468506Halyard614872026-05-22
10885632468513Halyard614882026-05-22
10885632468520Halyard614892026-05-22
10885632509032Halyard620732026-05-22
10885632509049Halyard620742026-05-22
10885632509056Halyard620752026-05-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048223131374Spinal Manometer NRFitPajunk GmbH MedizintechnologieFMJ2025-11-19
04048223131046Manometer Extension Tube - 20cmPajunk GmbH MedizintechnologieFMJ2025-06-17
04048223132425Manometer Extension Tube - 20cmPajunk GmbH MedizintechnologieFMJ2025-06-17
04048223069578Spinal ManometerPajunk GmbH MedizintechnologieFMJ2025-01-30
04048223048986Spinal ManometerPajunk GmbH MedizintechnologieFMJ2025-01-30
00849233008779Busse Hospital DisposablesROBERT BUSSE & CO., INC.FMJ2022-11-10
00849233008762Busse Hospital DisposablesROBERT BUSSE & CO., INC.FMJ2022-11-04
00849233008809Busse Hospital DisposablesROBERT BUSSE & CO., INC.FMJ2022-11-04
10849233008769Busse Hospital DisposablesROBERT BUSSE & CO., INC.FMJ2022-11-04
10849233008806Busse Hospital DisposablesROBERT BUSSE & CO., INC.FMJ2022-11-04
04048223049204MANOMETERPajunk GmbH MedizintechnologieFMJ2021-04-02
04048223049860MANOMETERPajunk GmbH MedizintechnologieFMJ2021-04-02
00849233004917Busse Hospital DisposablesROBERT BUSSE & CO., INC.FMJ2020-09-10
10849233004914Busse Hospital DisposablesROBERT BUSSE & CO., INC.FMJ2020-09-10
14048223022563Manometer Extension Tube - 20cmPajunk GmbH MedizintechnologieFMJ2020-07-15
04048223022566Manometer Extension Tube - 20cmPajunk GmbH MedizintechnologieFMJ2020-07-15
14048223029777Spinal Manometer NRFitPajunk GmbH MedizintechnologieFMJ2020-07-06
04048223029770Spinal Manometer NRFitPajunk GmbH MedizintechnologieFMJ2020-07-06
00849233000247Busse Hospital DisposablesROBERT BUSSE & CO., INC.FMJ2020-04-09
00849233003064Busse Hospital DisposablesROBERT BUSSE & CO., INC.FMJ2020-04-09
00849233010369Busse Hospital DisposablesROBERT BUSSE & CO., INC.FMJ2020-04-09
10849233000244Busse Hospital DisposablesROBERT BUSSE & CO., INC.FMJ2020-04-09
10849233003061Busse Hospital DisposablesROBERT BUSSE & CO., INC.FMJ2020-04-09
10849233010366Busse Hospital DisposablesROBERT BUSSE & CO., INC.FMJ2020-04-09
10884521020344CurityCardinal Health, Inc.FMJ2016-09-24
10884521020405CurityCardinal Health, Inc.FMJ2016-09-24
20884521020402CurityCardinal Health, Inc.FMJ2016-09-24
20884521020341CurityCardinal Health, Inc.FMJ2016-09-24
20884521020365CurityCardinal Health, Inc.FMJ2016-09-24
00849233004283Busse Hospital DisposablesROBERT BUSSE & CO., INC.FMJ2016-09-14