FDA UDI
In Commercial Distribution
🇺🇸 United States
Chrono-log
DI: 00811476010017
·
Model: 299-4
·
CHRONO-LOG CORP
Product Codes
1
GMDN Terms
1
Identifiers
9
Pkg Device Count
1
Basic Information
- Brand Name
- Chrono-log
- Primary DI
- 00811476010017
- Version / Model
- 299-4
- Company Name
- CHRONO-LOG CORP
- Labeler DUNS
- 002353696
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-11
- Public Version
- 4
- Public Version Date
- 2019-09-06
- Public Version Status
- Update
- Public Device Record Key
- 732d191c-fa6d-4e8f-ac48-db2d75d9aa32
Device Description
vW Reference Plasma Deficient
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| GGP | Test, Qualitative And Quantitative Factor Deficiency | Hematology | 864.7290 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56092 | Platelet aggregation study IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative evaluation of platelet aggregation in a clinical specimen using one or multiple platelet aggregation agents, which may include adenosine diphosphate, collagen, epinephrine, thrombin, arachidonic acid and/or ristocetin. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00811476010017 | GS1 | ||||
| Package | 811476010932 | GS1 | 9 | In Commercial Distribution | ||
| Package | 00811476011274 | GS1 | 2 | In Commercial Distribution | ||
| Package | 00811476011267 | GS1 | 8 | In Commercial Distribution | ||
| Package | 00811476011250 | GS1 | 7 | In Commercial Distribution | ||
| Package | 00811476011243 | GS1 | 6 | In Commercial Distribution | ||
| Package | 00811476011236 | GS1 | 5 | In Commercial Distribution | ||
| Package | 00811476011229 | GS1 | 4 | In Commercial Distribution | ||
| Package | 00811476011212 | GS1 | 3 | In Commercial Distribution |
Customer Contacts
- Phone
- 610-853-1130
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K945414 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius