FDA UDI
In Commercial Distribution
🇺🇸 United States
OCS Lung System
DI: B00939251
·
Model: 2464
·
TRANSMEDICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- OCS Lung System
- Primary DI
- B00939251
- Version / Model
- 2464
- Catalog Number
- 2464
- Company Name
- TRANSMEDICS, INC.
- Labeler DUNS
- 084445043
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-06-01
- Public Version
- 1
- Public Version Date
- 2018-07-02
- Public Version Status
- New
- Public Device Record Key
- 3250cb73-c5bc-4ee1-b455-4a17fc7d8a55
Device Description
OCS Lung Monitoring Gas Regulator Kit
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| QBA | Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62835 | Donor-organ preservation/transport system gas cylinder regulator | A reduction valve designed to be attached through a gastight connector (e.g., a pin-index or bull-nosed screw thread connection) to the valve stem of a donor-organ preservation/transport system gas cylinder to lower high, variable gas to a lower, constant working pressure. The regulated gas is typically a custom mix of oxygen, carbon dioxide and nitrogen used for preservation and/or evaluation of the extracorporeal organ. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | B00939313 | HIBCC | Cardboard Box | 1 | In Commercial Distribution | |
| Primary | B00939251 | HIBCC |
Customer Contacts
- Phone
- 9785520900
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 3 | Inch | |
| Width | 12 | Inch | |
| Length | 10 | Inch |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -20 – 50 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal