FDA UDI
In Commercial Distribution
🇺🇸 United States
HemoScreen
DI: 07290016991079
·
Model: CBC Sampler
·
PIXCELL MEDICAL TECHNOLOGIES LTD
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- HemoScreen
- Primary DI
- 07290016991079
- Version / Model
- CBC Sampler
- Catalog Number
- BC-MA-00100
- Company Name
- PIXCELL MEDICAL TECHNOLOGIES LTD
- Labeler DUNS
- 532623092
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-07-19
- Public Version
- 2
- Public Version Date
- 2022-10-07
- Public Version Status
- Update
- Public Device Record Key
- 72c53a76-ff77-4d5a-83c3-d5c989c361ab
Device Description
A disposable unit used for the collection of the blood sample
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GKZ | Counter, Differential Cell | Hematology | 864.5220 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57892 | Capillary blood collection tube IVD, K2EDTA | A non-sterile glass or plastic collection tube containing the anticoagulant dipotassium ethylene diamine tetraacetic acid (K2EDTA), intended to be used for the collection, preservation and/or transport of capillary blood for analysis or other investigation (e.g., microhaematocrit). It is typically sealed at one or both ends with a putty-like substance following specimen collection, It is This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 17290016991076 | GS1 | Catron or aluminum | 10 | In Commercial Distribution | |
| Primary | 07290016991079 | GS1 | ||||
| Package | 27290016991073 | GS1 | Aluminum bag | 25 | In Commercial Distribution | |
| Package | 37290016991070 | GS1 | Carton Box | 100 | Not in Commercial Distribution | 2022-10-06 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K180020 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 17 – 27 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 17 – 27 Degrees Celsius