FDA.report

UNBRANDED

Primary DI
10848340000000
Brand
UNBRANDED
Company
ADVANCE MEDICAL DESIGNS, INC.
Model
10-102
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
10848340000000PackageGS150In Commercial Distribution
00848340000003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1084834000000010848340000000
00848340000003008483400000038483400000030848340000003

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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10848340010320Miniview 6800 C-Arm Drape52616332024-04-10
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108483400102839600/9800/9900 Super C 12"52543822024-04-09
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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

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