FDA UDI
In Commercial Distribution
🇺🇸 United States
SourceMark
DI: 00813799004209
·
Model: M21014
·
SOURCEMARK, LLC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- SourceMark
- Primary DI
- 00813799004209
- Version / Model
- M21014
- Company Name
- SOURCEMARK, LLC.
- Labeler DUNS
- 121225812
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-08
- Public Version
- 2
- Public Version Date
- 2021-12-06
- Public Version Status
- Update
- Public Device Record Key
- e99f6f46-0e03-4d6b-bae9-635ce96eaf01
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
- Yes
- 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 |
|---|---|---|---|---|
| DWJ | System, Thermal Regulating | Cardiovascular | 870.5900 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36954 | Circulating-air whole-body heating system control unit | A mains electricity (AC-powered) device intended to be used as part of a circulating-air whole-body heating system to filter, and control/regulate the temperature and flow of room air through a connected patient-applied pad (not included), for heating a patient’s whole-body (i.e., elevate core body temperature to achieve normothermia). The device includes a filter, an air heater and air pump. It is intended to be used by a healthcare professional in a clinical setting. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10813799004213 | GS1 | Box | 10 | In Commercial Distribution | |
| Primary | 00813799004209 | GS1 | ||||
| Package | 20813799004227 | GS1 | Case | 4 | In Commercial Distribution |