DEVICE: Excyte® (03661540700675)
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Device Identifier (DI) Information
Excyte®
Plastic ESR Vacuum Tube High Altitude
Not in Commercial Distribution
ELITechGroup B.V.
Plastic ESR Vacuum Tube High Altitude
Not in Commercial Distribution
ELITechGroup B.V.
No description.
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? |
|---|---|---|---|---|
| 37558 | Evacuated erythrocyte sedimentation rate (ESR) tube IVD |
A sterile glass or plastic tube sealed with a stopper, or other dedicated vessel, containing a pre-measured amount of vacuum and the blood anticoagulant sodium citrate. It is intended to be used alone or in combination with other IVDs (e.g., ESR analyser, scaled measure) for the quantitative determination of the erythrocyte sedimentation rate (ESR) of a whole blood clinical specimen. This is a single-use device.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| GHC | Tube, Sedimentation Rate |
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
d5916274-040f-4054-a21b-26f8de36cac9
December 28, 2021
3
November 24, 2016
December 28, 2021
3
November 24, 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 |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
13661540700672
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined