FDA UDI
In Commercial Distribution
🇺🇸 United States
MEDRAD® Mark 7 Arterion Footswitch
DI: 00616258025308
·
Model: ART 700 FS
·
BAYER MEDICAL CARE INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MEDRAD® Mark 7 Arterion Footswitch
- Primary DI
- 00616258025308
- Version / Model
- ART 700 FS
- Catalog Number
- ART 700 FS
- Company Name
- BAYER MEDICAL CARE INC.
- Labeler DUNS
- 058716649
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-04-15
- Public Version
- 1
- Public Version Date
- 2022-04-25
- Public Version Status
- New
- Public Device Record Key
- 3b06ab2b-22f5-42f4-9b32-ff89baceb914
Device Description
ASSY,FOOTSWITCH,ARTERION,LR,UDI (87978494)
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 | 00616258025308 | GS1 |
Customer Contacts
- Phone
- +1(800)633-7231
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K112086 | 000 |
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 5 – 100 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- -20 – 60 Degrees Celsius