FDA.reportPublic FDA data

UNBRANDED

Primary DI
10848340000031
Brand
UNBRANDED
Company
ADVANCE MEDICAL DESIGNS, INC.
Model
10-108
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
LHISet, i.V. Fluid transfer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LHISet, I.V. Fluid TransferGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10848340000031PackageGS150In Commercial Distribution
00848340000034PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084834000003110848340000031
00848340000034008483400000348483400000340848340000034

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
07290108241518Vial2Bag Advanced 20mm Admixture DeviceWEST PHARMA. SERVICES IL, . LTDLHI2026-03-17
00827989007970Chemo VentHealth Care Logistics, Inc.LHI2026-03-04
00827989007987Venting NeedleHealth Care Logistics, Inc.LHI2026-03-04
28699443581892FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
28699443581915FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
28699443581922FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
28699443585296FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
28699443585302FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
28699443585319FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
28699443585326FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
28699443585333FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
00827989007826SuregripHealth Care Logistics, Inc.LHI2025-12-19
00827989007833SuregripHealth Care Logistics, Inc.LHI2025-12-19
00850025688291HyHub Vial Access DeviceTakeda Pharmaceuticals U.S.A., Inc.LHI2025-09-23
00850025688963HyHub Duo Vial Access DeviceTakeda Pharmaceuticals U.S.A., Inc.LHI2025-09-23
04063574200425nextaro® va 13, 5 µm Filtersfm medical devices GmbHLHI2025-09-05
20851891007609ArisureYUKON MEDICAL, LLCLHI2025-06-30
20851891007623ArisureYUKON MEDICAL, LLCLHI2025-05-23
10851891007299ArisureYUKON MEDICAL, LLCLHI2025-05-14
10851891007305ArisureYUKON MEDICAL, LLCLHI2025-05-14
10810110921389Mini Transfer PinMPS Pharma & Medical, Inc.LHI2025-04-28
10887709128009ICU Medical, Inc.ICU MEDICAL, INC.LHI2025-04-25
00860007260421IVX Station Reconstitution Transfer SetOmnicell, Inc.LHI2025-01-23
10851891007329ArisureYUKON MEDICAL, LLCLHI2024-11-27
10851891007350ArisureYUKON MEDICAL, LLCLHI2024-11-27
00347426505086ZYNRELEF 10 mL Vial Access Needle (VAN) ReplacementHeron Therapeutics, Inc.LHI2024-11-07
00347426506083ZYNRELEF 20 mL Vial Access Needle (VAN) ReplacementHeron Therapeutics, Inc.LHI2024-11-07
28699443580178FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2024-10-07
30815879021749IV PlusNEXUS MEDICAL, LLCLHI2024-09-16
30815879021756IV PlusNEXUS MEDICAL, LLCLHI2024-09-16