FDA UDI
In Commercial Distribution
🇺🇸 United States
OCS Heart System
DI: B00936363
·
Model: 1401
·
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
- B00936363
- Version / Model
- 1401
- Catalog Number
- 1401
- 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
- 1
- Public Version Date
- 2021-12-09
- Public Version Status
- New
- Public Device Record Key
- 4847a81f-7434-43f6-b642-0a040850ab73
Device Description
OCS Heart Instrumentation Tool 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 |
|---|---|---|---|---|
| 62833 | Donor-organ preservation/transport perfusion set connection kit | A collection of sterile devices and instruments intended to be used with a donor-organ preservation/transport perfusion set to enable connection of the perfusion set to the organ. It includes cannulae for vessel and/or organ connection and typically tubing cutters, tubing clamps, vessel ties and vessel tie tools. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B00936363 | HIBCC | ||||
| Package | B00936645 | HIBCC | Cardboard Box | 1 | 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 | 18 | Inch | |
| Width | 12 | Inch | |
| Height | 4 | Inch |
Storage Conditions
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- -20 – 50 Degrees Celsius