DEVICE: S-Monovette® (04038917366441)
Device Identifier (DI) Information
S-Monovette®
04.1933.100
In Commercial Distribution
04.1933.100
Sarstedt Aktiengesellschaft & Co.KG
04.1933.100
In Commercial Distribution
04.1933.100
Sarstedt Aktiengesellschaft & Co.KG
S-Monovette® 4.9ml FE
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? |
---|---|---|---|---|
57904 | Non-evacuated blood collection tube IVD, anticoagulant/antiglycolytic |
A non-evacuated glass or plastic tube, sealed with a stopper, containing an anticoagulant [e.g., ethylenediaminetetraacetic acid (EDTA), potassium oxalate, sodium heparin] and an antiglycolytic agent (e.g., sodium fluoride). It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation (e.g., blood glucose or lactate determinations). This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
2a8038e1-55a0-4ece-b799-259e066d449c
September 05, 2023
4
September 16, 2016
September 05, 2023
4
September 16, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
04038917366434 | 500 | 04038917366441 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
04038917366458
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
(800)257-5101
customerservice.us@sarstedt.com
customerservice.us@sarstedt.com