FDA UDI
In Commercial Distribution
🇺🇸 United States
MEDRAD® Mark 7 Arterion Footswitch
DI: 00616258027241
·
Model: ART 700 FS
·
Bayer Medical Care Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- MEDRAD® Mark 7 Arterion Footswitch
- Primary DI
- 00616258027241
- Version / Model
- ART 700 FS
- Catalog Number
- ART 700 FS
- Company Name
- Bayer Medical Care Inc.
- Labeler DUNS
- 049673973
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-06
- Public Version
- 1
- Public Version Date
- 2024-05-14
- Public Version Status
- New
- Public Device Record Key
- ad5c4d2a-d79b-46ee-81e4-e7a9d5766ffb
- Distribution End Date
- 9999-12-31
Device Description
ASSY,FOOTSWITCH,ARTERION,LR,UDI (89234522)
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 |
|---|---|---|---|---|
| DXT | Injector And Syringe, Angiographic | Cardiovascular | 870.1650 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36336 | Foot-switch, electrical | An electrically-powered pedal used by an operator of a medical device to regulate the activation and/or intensity of a parent device (e.g., electrosurgical system generator, laser, ophthalmic examination unit, dental drill/saw system control unit) to which it is connected, typically via an electrical cable. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00616258027241 | GS1 |
Customer Contacts
- Phone
- +1 800-633-7231
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K113133 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 60 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 5 – 100 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 48 – 106 KiloPascal