FDA UDI
In Commercial Distribution
🇺🇸 United States
OCS Heart System
DI: B00926340
·
Model: 1300
·
TRANSMEDICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- OCS Heart System
- Primary DI
- B00926340
- Version / Model
- 1300
- Catalog Number
- 1300
- Company Name
- TRANSMEDICS, INC.
- Labeler DUNS
- 084445043
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-12-01
- Public Version
- 2
- Public Version Date
- 2022-12-08
- Public Version Status
- Update
- Public Device Record Key
- 0c0fa2f7-22eb-4be0-9877-59af232844a7
Device Description
OCS Heart Solution Set
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QIK | Organ Care System (Ocs) Heart System | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 18004 | Donor-organ/tissue/cell preservation solution | A solution intended to be used for the flushing, transport, storage and preservation of donor cells, tissues and/or organs (e.g., stem cells, skin, amniotic membrane, cardiovascular tissue, bone, tendon, kidney, liver, heart, pancreas) intended for transplantation. The solution contains a mixture of chemicals/ingredients intended to maintain cell/tissue/organ viability until implantation in the recipient; some types may be combined with blood. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B00926340 | HIBCC | ||||
| Package | B00926341 | HIBCC | Cardboard Box | 4 | In Commercial Distribution |
Customer Contacts
- Phone
- 978-552-0900
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P180051 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 20 | Inch | |
| Width | 15 | Inch | |
| Height | 3 | Inch |
Storage Conditions
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 10 – 106 KiloPascal
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 25 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- DO NOT GET WET
- Type
- Special Storage Condition, Specify
- Special Conditions
- DO NOT EXPOSE TO DIRECT SUNLIGHT