FDA UDI
Not in Commercial Distribution
🇺🇸 United States
MYOtherm XP™
DI: 00763000218348
·
Model: XP41BT
·
MEDTRONIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- MYOtherm XP™
- Primary DI
- 00763000218348
- Version / Model
- XP41BT
- Company Name
- MEDTRONIC, INC.
- Labeler DUNS
- 006261481
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-06
- Public Version
- 3
- Public Version Date
- 2024-10-25
- Public Version Status
- Update
- Public Device Record Key
- 094c377e-fafd-4934-a5f4-781a6ae220b3
- Distribution End Date
- 2024-09-27
Device Description
CARDIOPLEGIA XP41BT MYOTHERM XP4 1BT 4PK
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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DTN | Reservoir, blood, cardiopulmonary bypass | Cardiovascular | 870.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16163 | Cardioplegia solution administration kit | A collection of devices intended to be used to infuse cardioplegia solution into the heart to interrupt its contractions during cardiopulmonary bypass surgery. It typically consists of tubing/adaptor, a filter, and a heat exchanger. This is single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20763000218342 | GS1 | PK | 4 | Not in Commercial Distribution | 2024-09-27 |
| Primary | 00763000218348 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K162958 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- – 50 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store the product at room temperature.