DEVICE: S-Monovette® (04038917271837)
Device Identifier (DI) Information
S-Monovette®
06.1669.100
In Commercial Distribution
06.1669.100
Sarstedt Aktiengesellschaft & Co.KG
06.1669.100
In Commercial Distribution
06.1669.100
Sarstedt Aktiengesellschaft & Co.KG
S-Monovette® 1.1ml LH-Gel
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? |
---|---|---|---|---|
46054 | Evacuated blood collection tube IVD, lithium heparin/gel separator |
A sterile glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum, the anticoagulant lithium heparin and a gel to separate plasma from cells. It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation (e.g., plasma chemistry determinations). This is a single-use device.
|
Obsolete | 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
37123122-2c28-49ff-87f8-cf1a4e4d11b8
April 01, 2020
3
September 16, 2016
April 01, 2020
3
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 |
---|---|---|---|---|---|
04038917271820 | 500 | 04038917271837 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
04038917271844
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
(800)257-5101
customerservice.us@sarstedt.com
customerservice.us@sarstedt.com