DEVICE: Hematype Segment Device (10810020440536)

Device Identifier (DI) Information

Hematype Segment Device
4R5128
In Commercial Distribution
4R5128
Fresenius Kabi AG
10810020440536
GS1

500
315654579 *Terms of Use
Hematype Segment Device
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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?
37566 Blood collection tube holder, single-use
A hand-held cylindrical device designed to be used together with an evacuated blood collection tube to draw blood samples from a patient. It is typically a hollow plastic adaptor into which the blood collection tube is inserted and to which the user attaches a hypodermic blood collection needle (not included); it may include an integrated blood collection tube spike. This device also facilitates a multiple-tube blood collection via one venipuncture. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
KSS Supplies, Blood-Bank
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
BK960083 0
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Sterilization

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

[?]
Storage and Handling
Special Storage Condition, Specify: Store at Room Temperature. Protect from freezing. Avoid excessive heat.
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Clinically Relevant Size

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

12c4724e-4713-485c-8388-94a901a3d2c0
August 17, 2023
2
November 08, 2022
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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
20810020440533 2 10810020440536 In Commercial Distribution Carton
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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

[?]
Unit of Use DI Number: 00810020440539 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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