FDA UDI
In Commercial Distribution
🇺🇸 United States
Cyto-Chex® BCT
DI: 40844509000837
·
Model: 230377
·
STRECK, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
Basic Information
- Brand Name
- Cyto-Chex® BCT
- Primary DI
- 40844509000837
- Version / Model
- 230377
- Catalog Number
- 230377
- Company Name
- STRECK, INC.
- Labeler DUNS
- 072915986
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2017-08-15
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 80e6f831-c9ae-4a00-96d7-34fbd1116b26
Device Description
A direct-draw blood collection tube for the preservation of whole blood specimens for immunophenotyping by flow cytometry. 2 ml vials.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| GIM | Tubes, Vacuum Sample, With Anticoagulant | Clinical Chemistry | 862.1675 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47588 | Evacuated blood collection tube IVD, K3EDTA | A sterile glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum and the anticoagulant tripotassium ethylene diamine tetraacetic acid (K3EDTA). It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation [e.g., whole blood haematology such as complete blood count (CBC), and quantitative drug assay determinations]. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 40844509000837 | GS1 | ||||
| Unit of Use | 00844509000839 | GS1 |
Customer Contacts
- Phone
- 1-800-228-6090
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K080552 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 2.0 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 18 – 30 Degrees Celsius