FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Excyte®
DI: 03661540700675
·
Model: Plastic ESR Vacuum Tube High Altitude
·
ELITechGroup B.V.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
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Basic Information
- Brand Name
- Excyte®
- Primary DI
- 03661540700675
- Version / Model
- Plastic ESR Vacuum Tube High Altitude
- Company Name
- ELITechGroup B.V.
- Labeler DUNS
- 415733737
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2016-11-24
- Public Version
- 3
- Public Version Date
- 2021-12-28
- Public Version Status
- Update
- Public Device Record Key
- d5916274-040f-4054-a21b-26f8de36cac9
- Distribution End Date
- 2021-12-23
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Radiation Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GHC | Tube, Sedimentation Rate | Hematology | 864.6700 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03661540700675 | GS1 | ||||
| Unit of Use | 13661540700672 | GS1 |