DEVICE: IV POLE ASSY 12 IN (00840682143684)

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Device Record History
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Device Identifier (DI) Information
IV POLE ASSY 12 IN
12 Inch IV1
In Commercial Distribution
0217-5378-800
Datex-Ohmeda, Inc.
00840682143684
GS1

1
118933716 *Terms of Use
IV POLE 12 IN
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
36069 Freestanding/bed-attached intravenous pole
A freestanding or equipment-attached metal rod with two or more hooked bars extending horizontally from its top from which various fluid delivery devices (bags or bottles) can be suspended for the administration of intravenous (IV) fluids/medication to the patient. It is used during infusion therapy for intravenous administration of fluids/solutions or blood transfusions. Infusion pumps and/or syringe pumps can also be attached to it. Also called an IV pole or drip pole, it can be a fixed or side-swinging, adjustable, vertical pole attached to a bed, operating table, wheelchair, or more commonly, an independent floor-standing IV pole for bedside use; some have wheels for patient mobility.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FOX Stand, Infusion
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Humidity: between 0 and 85 Percent (%) Relative Humidity
Storage Environment Temperature: between -25 and 60 Degrees Celsius
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
f5995281-1de7-484e-8340-8605df9136db
May 06, 2025
5
December 06, 2022
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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