FDA UDI
In Commercial Distribution
🇺🇸 United States
OCS Lung System
DI: B00938535
·
Model: 2200
·
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
- B00938535
- Version / Model
- 2200
- Catalog Number
- 2200
- 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
- 2
- Public Version Date
- 2020-09-07
- Public Version Status
- Update
- Public Device Record Key
- be6562d6-ad1f-4424-91e5-b8720075f6a1
Device Description
OCS Lung Perfusion 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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|
| 62831 | Lung donor-organ preservation/transport perfusion set | A collection of sterile devices intended to support and provide continuous physiologic organ perfusion to a donated lung(s) during its preservation, evaluation, and transport in a lung donor-organ preservation/transport system from the donor to the receiver hospital where the organ will be transplanted into the recipient. It typically includes a blood/fluid perfusion circuit, reservoir, pump, oxygenator, warmer, ventilator, flow/pressure sensors, access and control valves, cannulae/connectors/tools to connect the appropriate vessels of the lung(s), and tubing lines, filters and bags to add/remove blood and solutions. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B00938535 | HIBCC | ||||
| Package | B00938537 | HIBCC | Cardboard Box | 1 | In Commercial Distribution |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 21 | Inch | |
| Width | 27 | Inch | |
| Length | 27 | 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