NA
- Primary DI
- 00763000561826
- Brand
- NA
- Company
- MEDTRONIC, INC.
- Model
- 550-11
- Device description
- CALCIUM CHLORIDE 5 ML 550-11
- Published
- 2023-03-27
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Related Records
Contact Domains
medtronic.comProduct Codes
| Code | Name |
|---|---|
| GGN | Plasma, coagulation control |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| GGN | Plasma, Coagulation Control | Hematology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00763000561826 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00763000561826 | 00763000561826 | 763000561826 | 0763000561826 |
GMDN Terms
| Term | Definition |
|---|---|
| Multiple coagulation factor IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of one or multiple coagulation factors, coagulation intermediates and/or their activated components in a clinical specimen. |
Device Sizes
| Type | Value | Unit |
|---|---|---|
| Total Volume | 5 | Milliliter |
Storage And Handling
| Type | Low | High | Condition |
|---|---|---|---|
| Storage Environment Temperature | 2 Degrees Celsius | 25 Degrees Celsius | |
| Storage Environment Temperature | 35.6 Degrees Fahrenheit | 77 Degrees Fahrenheit |
Sterilization Methods
| Method |
|---|
Contacts
| Phone | |
|---|---|
| +1(800)633-8766 | Corporate.UDI@medtronic.com |
Regulatory Flags
- DUNS number
- 006261481
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00763000764234 | NA | CB11Z66R | 2022-12-23 | |
| 00763000764241 | NA | CB11Z68R | 2022-12-25 | |
| 00763000764319 | NA | HY2G71R9 | 2022-12-10 | |
| 00763000764951 | NA | BB12A73R | 2022-12-08 | |
| 00763000770419 | NA | 11Z79R1 | 2022-12-15 | |
| 00763000770433 | NA | BB12B18R | 2022-12-15 | |
| 00763000774127 | NA | BB11U49R3 | 2022-12-15 | |
| 00763000791421 | NA | BB11Y57R5 | 2022-12-22 | |
| 00763000810436 | NA | BB12A62R1 | 2022-12-23 | |
| 00763000810610 | NA | BB7M96R18 | 2022-12-23 | |
| 00763000810627 | NA | CB11Z63R | 2022-12-23 | |
| 00763000811723 | NA | BB12A02R | 2022-12-26 | |
| 00763000811754 | NA | BB7H85R26 | 2022-12-26 | |
| 00763000811785 | NA | BB12A46R1 | 2022-12-26 | |
| 00763000812126 | NA | HY7W39R35 | 2022-12-31 | |
| 00763000812133 | NA | BB12A69R1 | 2022-12-31 | |
| 00763000812157 | NA | CB9E90R6 | 2022-12-31 | |
| 00763000823580 | NA | HY11W68R3 | 2023-01-14 | |
| 00763000823597 | NA | HY11N74R14 | 2023-01-14 | |
| 00763000823795 | NA | HY12A49R1 | 2023-01-15 |
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| 00630414229515 | INNOVANCE Heparin UF Control 1 | Siemens Healthcare Diagnostics Products GmbH | GGN | 2024-03-25 |
| 00630414229539 | INNOVANCE Heparin LMW Control 1 | Siemens Healthcare Diagnostics Products GmbH | GGN | 2024-03-25 |
| 00842768019463 | Dade Ci-Trol Coagulation Control Level 2 | Siemens Healthcare Diagnostics Products GmbH | GGN | 2024-03-25 |
| 00842768019456 | Dade Ci-Trol Coagulation Control Level 3 | Siemens Healthcare Diagnostics Products GmbH | GGN | 2024-03-25 |
| 00842768019005 | ProC Control Plasma | Siemens Healthcare Diagnostics Products GmbH | GGN | 2024-03-25 |
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| 00815696021297 | George King Pooled Normal Plasma | GEORGE KING BIO-MEDICAL, INC | GGN | 2022-03-03 |
| 00815696021303 | George King Single Donor Normal Plasma | GEORGE KING BIO-MEDICAL, INC | GGN | 2022-03-03 |
| 00711234170345 | directCHECK ACT+ Whole Blood Control Level 1 | ACCRIVA DIAGNOSTICS HOLDINGS, INC. | GGN | 2022-01-21 |
| 00711234170352 | directCHECK ACT+ Whole Blood Control, Level 2 | ACCRIVA DIAGNOSTICS HOLDINGS, INC. | GGN | 2022-01-21 |
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