DEVICE: DIACLEAR (07332414066314)

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Device Identifier (DI) Information

DIACLEAR
106887
106887
GAMBRO INDUSTRIES
07332414066314
GS1
1
The DIACLEAR ultrafilter is intended to be used only with either HOSPAL Integra or Innova or GAMBRO Phonenix dialysis machines. It is indicated for purification of dialysis fluid to obtain microbiologically high quality dialysis fluid.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Intravenous line filter A sterile device designed to remove microorganisms and particulate matter from solutions in an infusion/intravenous (IV) line; it can also be used to remove air. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
FIP SUBSYSTEM, WATER PURIFICATION
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Sterilization

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

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Storage and Handling
Storage Environment Temperature: between 0 and 30 Degrees Celsius
Special Storage Condition, Specify: Store in a dry place
Storage Environment Temperature: between 32 and 86 Degrees Fahrenheit
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 24, 2016

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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
37332414066315 12 07332414066314 In Commercial Distribution CASE
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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)

[?]
No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+1(800)933-0303
Medinfo_medproducts@baxter.com
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