FDA.reportPublic FDA data

NEOMED*

Primary DI
10350770003341
Brand
NEOMED*
Company
Avanos Medical, Inc.
Model
LN2210
Catalog number
LN2210
Device description
LN2210 Lumbar Needle, 22G x 1.0" Spinal Needle
Published
2021-08-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PWYLumbar puncture tray (adult & pediatric)

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10350770003341PackageGS110In Commercial Distribution
00350770003344PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1035077000334110350770003341
00350770003344003507700033443507700033440350770003344

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass system air bubble/fluid level detectorA mains electricity (AC-powered) device designed to detect air bubbles in blood returned to the body from the extracorporeal circuit of a cardiopulmonary (heart-lung) bypass system, and to detect when blood falls below acceptable levels, typically in the venous drip chamber. The device typically consists of an electronic unit and ultrasonic sensors; it usually triggers alarms and activates automated mechanisms to turn off the blood flow when bubbles are detected or an abnormal fluid level occurs. It is typically an integral part of the cardiopulmonary bypass system.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(844)428-2667PIQ@AVANOS.COM

Regulatory Flags#

DUNS number
079375431
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
10680651458350Halyard4583525-0082017-09-18
10680651458367Halyard4583625-0102017-09-18
10680651458374Halyard4583725-0122017-09-18
10680651469035Halyard4690325-0142017-09-18
10680651469042Halyard4690425-0162017-09-18
10680651469059Halyard4690525-0182017-09-18
00193494135263AVANOS*500108750010872020-09-25
10680651124767COOLIEF* Cooled Radiofrequency QUICKCLAMP* Device12476SIA-QC2016-05-17
00812120005083Game Ready* 6' Dual Connector Hose, Rental120004997570302-RN2026-04-24
00812120005090Game Ready* 6' Medical Connector Hose, Rental120004999570304-RN2026-04-24
00812120005106Game Ready* Wrap Extender Strap Kit, Rental120004998573226-RN2026-04-17
00609038351117AVANOS35111351112020-04-01
00609038351124AVANOS35112351122020-04-01
00609038351131AVANOS35113351132020-04-01
00609038351148AVANOS35114351142020-04-01
00609038351155AVANOS35115351152020-04-01
00609038351162AVANOS35116351162020-04-01
00609038351179AVANOS35117351172020-04-01
00609038351186AVANOS35118351182020-04-01
00609038351193AVANOS35119351192020-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10198956233539CARDINAL HEALTHCardinal Health 200, LLCPWY2026-03-02
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10198956369375CARDINAL HEALTHCardinal Health 200, LLCPWY2026-02-17
50198956369373CARDINAL HEALTHCardinal Health 200, LLCPWY2026-02-17
10198956357976CARDINAL HEALTHCardinal Health 200, LLCPWY2026-02-13
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10198956095670CARDINAL HEALTHCardinal Health 200, LLCPWY2025-07-10
50198956095678CARDINAL HEALTHCardinal Health 200, LLCPWY2025-07-10
10198956073760CARDINAL HEALTHCardinal Health 200, LLCPWY2025-06-13
50198956073768CARDINAL HEALTHCardinal Health 200, LLCPWY2025-06-13
10198956082106CARDINAL HEALTHCardinal Health 200, LLCPWY2025-05-22
10197106993941CARDINAL HEALTHCardinal Health 200, LLCPWY2025-04-18