DEVICE: TWOFER (00085412478425)

Device Identifier (DI) Information

TWOFER
H93819035
In Commercial Distribution
H93819035
BAXTER CORPORATION ENGLEWOOD
00085412478425
GS1

1
078383477 *Terms of Use
TWOFER Huber-Tipped Needle
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Device Characteristics

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

GMDN

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

GMDN Preferred Term Name GMDN Definition
Medication transfer needle, basic A sterile, slender, sharply-pointed metal tube typically intended to be used in the pharmacy to transfer medication from a vial to another container. It consists of a short needle sufficient to penetrate the vial stopper and extract all the medication. It is typically of 20 gauge to provide a high flow rate with minimum coring. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
LHI Set, i.V. Fluid transfer
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K832347 000
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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
No storage/handling found
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Clinically Relevant Size

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Size Type Text
Needle Gauge: 16 Gauge
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Device Record Status

e4b5dbab-ccb3-43e3-add3-96442d658193
July 06, 2018
3
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
20085412478429 100 00085412478425 In Commercial Distribution BOX
50085412478420 500 20085412478429 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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

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