FDA.reportPublic FDA data

GUARDIAN

Primary DI
50630140041523
Brand
GUARDIAN
Company
Cardinal Health 200, LLC
Model
1-319CE
Catalog number
1-319CE
Device description
1200 GII Kit W/6MM X 9' Tube
Published
2016-06-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
GCXAPPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCXApparatus, Suction, Operating-Room, Wall Vacuum PoweredGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50630140041523PrimaryGS10
00630140041528Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5063014004152350630140041523
00630140041528006301400415286301400415280630140041528

GMDN Terms#

Term, Definition table
TermDefinition
Suction system canister linerA device made of disposable materials used to cover the inner surface of a suction system reusable canister, for the collection of substances such as blood, bodily fluids, rinsing fluids, body tissue, or gas (e.g., laser plume evacuation) from a site of operation. The device may be soft-walled, or it may have walls of semi-rigid plastic with a dedicated lid. Together with the canister, it can be used singularly, or in a connected series to provide greater capacity. This device should be discarded, including its contaminated waste content, according to the environmental legislation by which the user is bound (e.g., incineration, recycling, landfill). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0
Lumen/Inner Diameter0
Total Volume0

Regulatory Flags#

DUNS number
961027315
Device count
30
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10197106992753CARDINAL HEALTHSCV40VP52CSCV40VP52C2026-09-25
10198956169357CARDINAL HEALTHSCV69EVWKASCV69EVWKA2026-09-25
10198956172715CARDINAL HEALTHSBA21PPSCCSBA21PPSCC2026-09-25
10198956321335CARDINAL HEALTHPEHDTRVCKPEHDTRVCK2026-09-25
10198956339729CARDINAL HEALTHSBA22ATMRASBA22ATMRA2026-09-25
10198956374232CARDINAL HEALTHSOP41KASRBSOP41KASRB2026-09-25
10198956383043CARDINAL HEALTHORC3R7765BORC3R7765B2026-09-25
10198956388239CARDINAL HEALTHSOT53CYPOFSOT53CYPOF2026-09-25
10198956393288CARDINAL HEALTHSBA73GPMVBSBA73GPMVB2026-09-25
10198956400801CARDINAL HEALTHSOP3MHPCVCSOP3MHPCVC2026-09-25
10198956402522CARDINAL HEALTHSMA13GLEXDSMA13GLEXD2026-09-25
10198956424654CARDINAL HEALTHPO54TKCMDPO54TKCMD2026-09-25
10198956439849CARDINAL HEALTHSAN69PCKOGSAN69PCKOG2026-09-25
10198956444263CARDINAL HEALTHPV36HPCHEPV36HPCHE2026-09-25
10198956450684CARDINAL HEALTHSMA58CSLOPSMA58CSLOP2026-09-25
10198956461086CARDINAL HEALTHSBACGBPGSHSBACGBPGSH2026-09-25
10198956462205CARDINAL HEALTHPV08TCGHHPV08TCGHH2026-09-25
10198956466159CARDINAL HEALTH03-2656S03-2656S2026-09-25
10198956466838CARDINAL HEALTHSNE35LSFSGSNE35LSFSG2026-09-25
10198956484382CARDINAL HEALTHANE306276AANE306276A2026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840117320987Resp-O2 Suction Canister Rings, Compatible With 800 cc and 1200 cc CanisterDynarex CorporationGCX2026-09-25
10198956534681CARDINAL HEALTHCardinal Health 200, LLCGCX2026-07-27
10192253043365CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
10192253043372CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
10192253043389CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
10192253043396CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
10192253043402CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
10192253043419CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
08682952420093DeRoyalPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIGCX2025-11-06
00848530084011Oxygen AccessorySunset Healthcare Solutions, Inc.GCX2025-06-18
00848530099640Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCX2025-05-21
00848530103996Oxygen AccessorySunset Healthcare Solutions, Inc.GCX2025-05-14
00848530104009Oxygen Wrench and Washer KitSunset Healthcare Solutions, Inc.GCX2025-05-14
00848530105464Washer with Rubber Ring - AluminumSunset Healthcare Solutions, Inc.GCX2025-05-14
08682952418014PergoPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIGCX2025-05-13
00848530105747Oxygen AccessorySunset Healthcare Solutions, Inc.GCX2025-05-12
00848530105754Oxygen AccessorySunset Healthcare Solutions, Inc.GCX2025-05-12
00848530105723Oxygen AccessorySunset Healthcare Solutions, Inc.GCX2025-05-12
00848530105730Oxygen AccessorySunset Healthcare Solutions, Inc.GCX2025-05-12
08682952418144DeRoyalPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIGCX2025-05-08
08682952417437DeRoyalPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIGCX2025-05-07
08682952417451DeRoyalPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIGCX2025-05-07
08682952417482DeRoyalPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIGCX2025-05-07
10192253041736ArgyleCardinal Health 200, LLCGCX2025-03-24
10192253041743ArgyleCardinal Health 200, LLCGCX2025-03-24
10192253041750ArgyleCardinal Health 200, LLCGCX2025-03-24
10192253038965ArgyleCardinal Health 200, LLCGCX2025-02-28
10192253038972ArgyleCardinal Health 200, LLCGCX2025-02-28
10192253038989ArgyleCardinal Health 200, LLCGCX2025-02-28
10192253038996ArgyleCardinal Health 200, LLCGCX2025-02-28