FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 20613994697251
·
Model: 304-10POR
·
MEDTRONIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
9
Basic Information
- Brand Name
- NA
- Primary DI
- 20613994697251
- Version / Model
- 304-10POR
- Company Name
- MEDTRONIC, INC.
- Labeler DUNS
- 006261481
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 9
- Record Status
- Published
- Publish Date
- 2016-06-13
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 8b46e84b-e476-4d9c-b603-9bc723193ab6
Device Description
CRTG 304-10POR PORC HMS PRP 5L INT 9PK
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 |
|---|---|---|---|---|
| 56195 | Heparin anti-Xa IVD, kit, chromogenic | A collection of reagents and other associated materials intended to be used for the quantitative detection of heparin by measuring its ability to inhibit the activity of activated factor X (factor Xa) in a clinical specimen, using a chromogenic method. The assay is typically used to monitor anticoagulation therapy. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 20613994697251 | GS1 | ||||
| Unit of Use | 00613994697257 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K922031 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Range: 4.5-6.0MG/KG |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Refrigerated 2°C-10°C
- Type
- Special Storage Condition, Specify
- Special Conditions
- Room Temperature 10°C-25°C