DEVICE: S-Monovette® (04038917238526)

Device Identifier (DI) Information

S-Monovette®
04.1917.100
In Commercial Distribution
04.1917.100
Sarstedt Aktiengesellschaft & Co.KG
04038917238526
GS1

50
388000270 *Terms of Use
S-Monovette® 2.7ml K3E
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
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
Evacuated blood collection tube IVD, K3EDTA A sterile glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum and the anticoagulant tripotassium ethylene diamine tetraacetic acid (K3EDTA). It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation [e.g., whole blood haematology such as complete blood count (CBC), and quantitative drug assay determinations]. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes 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

c6e14eab-2f9d-49d9-9ecc-2bbc52f1c50d
March 29, 2018
2
September 16, 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
04038917238519 500 04038917238526 In Commercial Distribution
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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: 04038917238533 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
(800)257-5101
customerservice@sarstedt.com
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