FDA UDI
In Commercial Distribution
🇺🇸 United States
Excyte® ESR Non-Vacuum Tubes
DI: 03661540300240
·
Model: EX-50100
·
ELITECHGROUP INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Excyte® ESR Non-Vacuum Tubes
- Primary DI
- 03661540300240
- Version / Model
- EX-50100
- Catalog Number
- EX-50100
- Company Name
- ELITECHGROUP INC.
- Labeler DUNS
- 052423787
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-01
- Public Version
- 1
- Public Version Date
- 2023-10-09
- Public Version Status
- New
- Public Device Record Key
- fe1b9f64-7f0b-41d2-9183-86f6457c4e4c
Device Description
ESR Tubes are single use devices intended to be used as whole blood sample tubes for the quantitative determination of Erythrocyte Sedimentation Rate (ESR) using ELITechGroup ESR analyzers. These devices are to be used by trained medical personnel only. The ESR tubes are intended for IN VITRO DIAGNOSTIC USE ONLY (IVD).
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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GKB | Device, Automated Sedimentation Rate | Hematology | 864.5800 | 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 | 03661540300240 | GS1 |
Customer Contacts
- Phone
- (800) 453 2725
- [email protected]