FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50630140038073
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
ASU1520
Catalog number
ASU1520
Device description
INSUFFLATION TUBING SET
Published
2016-07-22
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
NKCTubing/tubing with filter, insufflation, laparoscopic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKCTubing/Tubing With Filter, Insufflation, LaparoscopicObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50630140038073PackageGS110In Commercial Distribution
10630140038075PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5063014003807350630140038073
1063014003807510630140038075

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic insufflation tubing set, single-useA collection of sterile flexible tubing intended to be used as a conduit to deliver a medical gas [e.g., carbon dioxide (CO2), medical air] from its source for insufflation during an endoscopic (including laparoscopic, arthroscopic) procedure. It includes synthetic polymer tubing and associated connectors; it may in addition be intended for endoscopic lens drying, and may include tubing for delivery of a sterile irrigation solution for endoscopic irrigation. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885380213281CARDINAL HEALTHCAH4403CAH44032026-05-27
10192253047486Telfa766776672025-09-08
50885380140233CONVERTORS8337N8337N2018-08-20
10192253047967Kendall92339233-2026-05-26
20192253019992Kendall33547T33547T--2026-05-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25
10198956328457CARDINAL HEALTHPG4ETRHTCPG4ETRHTC2026-05-25
10198956340435CARDINAL HEALTH08-4609B08-4609B2026-05-25
10198956345645CARDINAL HEALTHSEYCGVPCPHSEYCGVPCPH2026-05-25
10198956348189CARDINAL HEALTHSBA48PPNSESBA48PPNSE2026-05-25
10198956350205CARDINAL HEALTHORC431774CORC431774C2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840493412498RIVA Posterior Fixation SystemXENIX MEDICAL LLCNKC2026-02-16
00840493412535RIVA Posterior Fixation SystemXENIX MEDICAL LLCNKC2026-02-16
15060120950571Insufflation FilterGVS FILTER TECHNOLOGY UK LTDNKC2025-12-11
16931918171258AllesetGRI Medical & Electronic Technology Co., Ltd.NKC2025-12-09
26931918171255AllesetGRI Medical & Electronic Technology Co., Ltd.NKC2025-12-09
30326053102791Regard™Resource Optimization & Innovation, L.L.C.NKC2025-11-21
04711605992053The O R Company - InsufflatOR Tubing SetADVANCED MEDICAL DESIGN CO., LTD.NKC2025-07-28
04048551067444NAKarl Storz GmbH & Co. KGNKC2025-03-28
04048551326664NAKarl Storz GmbH & Co. KGNKC2025-03-28
00817183020813PUREPNEUMO Tubing SetNORTHGATE TECHNOLOGIES INC.NKC2024-07-09
10817183020810PUREPNEUMO Tubing SetNORTHGATE TECHNOLOGIES INC.NKC2024-07-09
04055207070093NARichard Wolf GmbHNKC2024-05-24
04055207070109NARichard Wolf GmbHNKC2024-05-24
04897106955862andorate® CO2 Source Tubing AdapterGA Health Company LimitedNKC2023-08-30
14897106955869andorate® CO2 Source Tubing AdapterGA Health Company LimitedNKC2023-08-30
04897106955855andorate® CO2 Source Tubing AdapterGA Health Company LimitedNKC2023-08-28
14897106955852andorate® CO2 Source Tubing AdapterGA Health Company LimitedNKC2023-08-28
00628725007366SterisCanadian Hospital Specialties LimitedNKC2023-08-23
00628725007373SterisCanadian Hospital Specialties LimitedNKC2023-08-23
00628725007380SterisCanadian Hospital Specialties LimitedNKC2023-08-23
00628725007397SterisCanadian Hospital Specialties LimitedNKC2023-08-23
50628725007361CHSCanadian Hospital Specialties LimitedNKC2023-08-23
50628725007378CHSCanadian Hospital Specialties LimitedNKC2023-08-23
50628725007385CHSCanadian Hospital Specialties LimitedNKC2023-08-23
50628725007392CHSCanadian Hospital Specialties LimitedNKC2023-08-23
30326053102784Regard™Resource Optimization & Innovation, L.L.C.NKC2023-07-28
30326053102807Regard™Resource Optimization & Innovation, L.L.C.NKC2023-07-28
30326053102814Regard™Resource Optimization & Innovation, L.L.C.NKC2023-07-28
20326053102787Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.NKC2023-07-28
20326053102800Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.NKC2023-07-28