FDA UDI
In Commercial Distribution
🇺🇸 United States
N/A
DI: 20763000014760
·
Model: 306-02POR
·
MEDTRONIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- N/A
- Primary DI
- 20763000014760
- Version / Model
- 306-02POR
- Company Name
- MEDTRONIC, INC.
- Labeler DUNS
- 006261481
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2021-11-12
- Public Version
- 1
- Public Version Date
- 2021-11-22
- Public Version Status
- New
- Public Device Record Key
- ca6b5d80-76c4-49f2-a1e6-f8dcee0947bd
Device Description
CONTROL 306-02POR PORC HMS TAN/SIL 10BX
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| JOX | ANALYZER, HEPARIN, AUTOMATED | Hematology | 864.5680 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35505 | Coagulation timer IVD | An electronic device that is used to measure, indicate, and/or record the length of time taken for plasma or a whole blood sample to form a clot following the initiation of a reaction, typically as part of in vitro coagulation studies. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00763000014766 | GS1 | ||||
| Primary | 20763000014760 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K894317 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Once reconstituted, controls are stable for 2 hours at refrigerated or room temperature (2°C to 25°C [35.6°F to 77°F])
- Type
- Special Storage Condition, Specify
- Special Conditions
- Lyophilized heparin assay controls must be refrigerated (2°C to 10°C [35.6°F to 50°F]) until use.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Temperature Limit 2°C-10°C