FDA.report

UNBRANDED

Primary DI
10848340000017
Brand
UNBRANDED
Company
ADVANCE MEDICAL DESIGNS, INC.
Model
10-104
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

Related Records

Product Codes

CodeName
KPECONTAINER, I.V.

Product Code Classifications

CodeDeviceSpecialtyClass
KPEContainer, I.V.General Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10848340000017PackageGS150In Commercial Distribution
00848340000010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1084834000001710848340000017
00848340000010008483400000108483400000100848340000010

GMDN Terms

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
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

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