FDA UDI
In Commercial Distribution
🇺🇸 United States
HEPline®
DI: 00763000014902
·
Model: 313-50
·
MEDTRONIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- HEPline®
- Primary DI
- 00763000014902
- Version / Model
- 313-50
- Company Name
- MEDTRONIC, INC.
- Labeler DUNS
- 006261481
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-23
- Public Version
- 1
- Public Version Date
- 2023-07-31
- Public Version Status
- New
- Public Device Record Key
- da0e0d0c-4bd0-4823-b2bc-cf32a0330b7b
Device Description
LINEARITY KIT 313-50 HEPLINE
Device Characteristics
- Single Use
- No
- 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 |
|---|---|---|---|---|
| JPA | SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES | Hematology | 864.5425 | 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 |
|---|---|---|---|---|---|---|
| Primary | 00763000014902 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K981815 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 10 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- The kit must be used by the room temperature date or by the printed refrigerated Use- By Date, whichever comes first.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store tubes in the box until the time of use.
- Type
- Special Storage Condition, Specify
- Special Conditions
- If removed from refrigeration, the kit may be stored at room temperature (10°C to 25°C) for up to 7 days