FDA UDI
In Commercial Distribution
🇺🇸 United States
Actalyke Mini II, w/o Printer & Battery, "CE 2009" (110V/220V)
DI: M52557550010
·
Model: 5755001
·
HELENA LABORATORIES CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Actalyke Mini II, w/o Printer & Battery, "CE 2009" (110V/220V)
- Primary DI
- M52557550010
- Version / Model
- 5755001
- Company Name
- HELENA LABORATORIES CORPORATION
- Labeler DUNS
- 836287433
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-22
- Public Version
- 4
- Public Version Date
- 2023-09-11
- Public Version Status
- Update
- Public Device Record Key
- cae67b00-7600-4803-87c8-27a5801c7e9c
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JBP | ACTIVATED WHOLE BLOOD CLOTTING TIME | Hematology | 864.7140 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56689 | Coagulation analyser IVD, laboratory | An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of one or multiple coagulation components involved in haemostasis in a clinical specimen [e.g., performs tests such as prothrombin time (PT), partial thromboplastin time (PTT)]. Analyser design may incorporate spectrophotometry, turbidimetry, nephelometry, electrometry, electromagnetic and/or mechanical means of clot formation or end point detection. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M52557550010 | HIBCC |
Customer Contacts
- Phone
- +1(800)231-5663 ext. 1600
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K013078 | 000 |