DEVICE: EXEL 5ML CLEAR HLDR, Non-Sterile (00020221265316)

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Device Record History
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Device Identifier (DI) Information
EXEL 5ML CLEAR HLDR, Non-Sterile
26531
In Commercial Distribution
26531
Exel International
00020221265316
GS1

1
180572216 *Terms of Use
EXEL 5ML CLEAR HLDR, Non-Sterile 1,000PCS/DOUBLE BAG PER CASE
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
No
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?
58284 Blood collection tube holder/needle
A sterile, hand-held cylindrical device with a pre-attached needle 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 with a pre-attached blood collection needle at one end and into which the blood collection tube is inserted at the other end; this 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
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
FMH Container, Specimen, Sterile
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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

[?]
Storage and Handling
Storage Environment Temperature: between 15 and 25 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
14d4576e-bac5-4522-93a6-76316448eb8d
March 24, 2023
1
March 16, 2023
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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
10020221265313 1000 00020221265316 In Commercial Distribution Bag
20020221265310 1 10020221265313 In Commercial Distribution Outer box
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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: 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

[?]
No Customer Contact currently defined
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