DEVICE: ALL-IN-ONE (00085412043869)

Device Identifier (DI) Information

ALL-IN-ONE
2B8114
In Commercial Distribution
2B8114
BAXTER INTERNATIONAL INC.
00085412043869
GS1

1
005146311 *Terms of Use
ALL-IN-ONE Container, Empty EVA Container with Three Lead Transfer Set, 1000 mL Capacity
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
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 fluid container, single-use A container made of plastic or glass used to hold a fluid mixture to be administered to a patient through an intravenous (IV) administration set. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
KPE CONTAINER, I.V.
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K090096 000
No CLOSE

Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

3ecd99ae-e800-433b-b5c6-19db486590aa
July 06, 2018
3
September 24, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
50085412043864 20 00085412043869 In Commercial Distribution CASE
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Secondary DI

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

[?]
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

[?]
Yes
No
No
No
No CLOSE

Customer Contact

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