FDA UDI
In Commercial Distribution
🇺🇸 United States
Midas Rex
DI: 00763000337513
·
Model: PA200
·
MEDTRONIC POWERED SURGICAL SOLUTIONS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Midas Rex
- Primary DI
- 00763000337513
- Version / Model
- PA200
- Company Name
- MEDTRONIC POWERED SURGICAL SOLUTIONS
- Labeler DUNS
- 098308849
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-11-01
- Public Version
- 1
- Public Version Date
- 2020-11-09
- Public Version Status
- New
- Public Device Record Key
- cb5c5450-ab22-46f8-8c25-9e8871b20217
Device Description
ACCY PA200 MIDAS REX REGULATOR DISS
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
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- High-level Disinfectant
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BXH | GAUGE, GAS PRESSURE, CYLINDER/PIPELINE | Anesthesiology | 868.2610 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47860 | Surgical air pipeline regulator | A reduction valve designed to lower high and variable gas pressure in a pipeline intended for surgical applications (e.g., to drive surgical power tools) to a lower and constant working pressure, typically 3 - 12 bar. It consists of a housing containing a single- or dual-stage regulator used to regulate the surgical air, connectors (these may be permanent or quick connectors), and a pressure gauge; it may include an integral filter to remove possible contaminants, sometimes with a glass bowl for the collection of oil deposits and for observation. It is typically made of metal and synthetic polymer materials. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00763000337513 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K183515 | 000 |