FDA.reportPublic FDA data

UNBRANDED

Primary DI
10848340000048
Brand
UNBRANDED
Company
ADVANCE MEDICAL DESIGNS, INC.
Model
10-110
Device description
Decanter
Published
2016-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
KPECONTAINER, I.V.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPEContainer, I.V.General Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10848340000048PackageGS150In Commercial Distribution
00848340000041PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084834000004810848340000048
00848340000041008483400000418483400000410848340000041

GMDN Terms#

Term, Definition table
TermDefinition
Fluid transfer set, general-purposeA collection of sterile devices and supplies designed to transfer several types of medical fluids (e.g., drugs, vaccines, blood, and solutions) between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
130785884
Device count
1
DM exempt
true
Premarket exempt
false
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10848340010719C-FlexA-707022026-03-12
10848340010481Mitaka DrapeMU51512024-04-17
10848340011464Mitaka Spy EliteMU1202024-04-17
10848340015530Rolled Probe Cover29-PCS28212024-04-16
10848340016834Rolled Probe Cover29-PCS3520LF2024-04-16
10848340016858Rolled Probe Cover29-PCS0330LF2024-04-16
10848340015547Rolled Probe Cover29-PCS35202024-04-15
10848340012089Sterile Elastic BandsBRB6-5X22024-04-14
10848340015486C-Arm Pack10-21762024-04-14
10848340010160Celfina Cover Motor Module10053442024-04-10
1084834001030612" II Tube Drape (36X36)52584972024-04-10
10848340010320Miniview 6800 C-Arm Drape52616332024-04-10
10848340010276Wide Footswitch Cover52534302024-04-09
108483400102839600/9800/9900 Super C 12"52543822024-04-09
108483400102909600/9800/9900 C-Arm Consu.52559362024-04-09
10848340010238Universal 1/2 Drape52333452024-04-08
10848340010245Gray Footswitch Cover52382592024-04-08
10848340017008Leap Med28-TPUA1702024-04-03
10848340017275Leap Med28-TPUA1722024-04-03
10848340016988Leap Med28-TPU1662024-04-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850033629446Acta MedicalActa Medical LLCKPE2026-02-26
18056209145102EVA TPN BAGSVALMED SRLKPE2026-02-02
18056209145119EVA TPN BAGSVALMED SRLKPE2026-02-02
28033737862289EVA TPN BagsVALMED SRLKPE2025-12-31
38859299136135eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-09-11
38859299136142eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-09-11
38859299136159eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-09-11
10192253056709ChemoPlusCardinal Health 200, LLCKPE2025-08-22
10192253056716ChemoPlusCardinal Health 200, LLCKPE2025-08-22
38859299136173eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-07-31
38859299136036eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-06-06
38859299136043eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-06-06
38859299136067eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-06-06
38859299136074eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-06-06
38859299136081eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-06-06
38859299136111eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-06-06
00860013851200International Filter Products, doing business as IFP MedicalINTERNATIONAL FILTER PRODUCTS, INC.KPE2025-05-09
00860013851217International Filter Products, doing business as IFP MedicalINTERNATIONAL FILTER PRODUCTS, INC.KPE2025-05-09
00860013851224International Filter Products, doing business as IFP MedicalINTERNATIONAL FILTER PRODUCTS, INC.KPE2025-05-09
00860013851231International Filter Products, doing business as IFP MedicalINTERNATIONAL FILTER PRODUCTS, INC.KPE2025-05-09
00860013851248International Filter Products, doing business as IFP MedicalINTERNATIONAL FILTER PRODUCTS, INC.KPE2025-05-09
00860013851255International Filter Products, doing business as IFP MedicalINTERNATIONAL FILTER PRODUCTS, INC.KPE2025-05-09
00860013851262International Filter Products, doing business as IFP MedicalINTERNATIONAL FILTER PRODUCTS, INC.KPE2025-05-09
00860013851279International Filter Products, doing business as IFP MedicalINTERNATIONAL FILTER PRODUCTS, INC.KPE2025-05-09
10810110921198IMed ProductsINTEGRATED MEDICAL SYSTEMS, INC.KPE2025-04-22
10810110921204IMed ProductsINTEGRATED MEDICAL SYSTEMS, INC.KPE2025-04-22
10810110921211IMed ProductsINTEGRATED MEDICAL SYSTEMS, INC.KPE2025-04-22
10853155008370IMed ProductsINTEGRATED MEDICAL SYSTEMS, INC.KPE2025-04-22
10853155008387IMed ProductsINTEGRATED MEDICAL SYSTEMS, INC.KPE2025-04-22
20853155008292IMed ProductsINTEGRATED MEDICAL SYSTEMS, INC.KPE2025-04-22