FDA.report

AMTRION Infusion S-0725-F-2-S

Primary DI
04260217220332
Brand
AMTRION Infusion S-0725-F-2-S
Company
Amtrion GmbH
Model
3001-01-1-902
Published
2025-12-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FOXStand, Infusion

Product Code Classifications

CodeDeviceSpecialtyClass
FOXStand, InfusionGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04260217220332PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04260217220332042602172203324260217220332

GMDN Terms

TermDefinition
Wall-mounted intravenous hangerA device that is designed to be attached directly to a wall, a wall fixture (a mounting) or other vertical structure and is used to function as an intravenous (IV) hanger. It will typically have one or more horizontally extended arms with a hook at the far end; the arm may be fixed at a ninety degree angle to the wall or can swing in an arc to the wall. Various fluid delivery devices (bags or bottles) can be suspended from this device for the administration of intravenous (IV), irrigation, enteral feeding fluids/medication to the patient. Wall-mounted IV poles are mainly used in healthcare areas where administration of IV fluids is frequent and/or the use of the floor space is critical.

Storage And Handling

TypeLowHighCondition
Storage Environment Atmospheric Pressure70 KiloPascal110 KiloPascal
Storage Environment Humidity20 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius70 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+49573176070info@amtrion.com

Regulatory Flags

DUNS number
315983452
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
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 DIBrandModelCatalogPublished
04260217222176AMTRION Claw 40254025-00-0-000-022026-05-26

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00810050863384ServiPlexLIFEPORT, LLCFOX2026-02-19
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00810050863360Transition DeckLIFEPORT, LLCFOX2026-01-27
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00841027103233Pedigo Products, Inc.PEDIGO PRODUCTS, INC.FOX2026-01-08
00761887005358BaxterPRYOR PRODUCTSFOX2026-01-05
00761887005341PryorPRYOR PRODUCTSFOX2025-12-31
00041298995166HealthSmartD-M-S HOLDINGS, INC.FOX2025-12-29
06973456941064CORITONCORITON Instrument Co.,LtdFOX2025-12-29
06973456941071CORITONCORITON Instrument Co.,LtdFOX2025-12-29
04061162087212CIM med GmbHCIM med GmbHFOX2025-12-14
00841027103226Pedigo Products, Inc.PEDIGO PRODUCTS, INC.FOX2025-11-29
06973456941033CORITONCORITON Instrument Co.,LtdFOX2025-11-27
00841027100324Pedigo Products, Inc. PEDIGO PRODUCTS, INC.FOX2025-11-26
00841027102472Pedigo Products, Inc. PEDIGO PRODUCTS, INC.FOX2025-11-26
00841027102489Pedigo Products, Inc. PEDIGO PRODUCTS, INC.FOX2025-11-26
00841027102496Pedigo Products, Inc. PEDIGO PRODUCTS, INC.FOX2025-11-26
00841027102502Pedigo Products, Inc. PEDIGO PRODUCTS, INC.FOX2025-11-26