FDA UDI
In Commercial Distribution
🇺🇸 United States
810X - CPRotector® - w/Nitrile Gloves - 2/Unit
DI: 00766588160702
·
Model: R216-070
·
Certified Safety Manufacturing, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- 810X - CPRotector® - w/Nitrile Gloves - 2/Unit
- Primary DI
- 00766588160702
- Version / Model
- R216-070
- Catalog Number
- R216-070
- Company Name
- Certified Safety Manufacturing, Inc.
- Labeler DUNS
- 788460483
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-11-16
- Public Version
- 1
- Public Version Date
- 2018-12-17
- Public Version Status
- New
- Public Device Record Key
- 8e773511-3042-4a19-8130-c133ea196f1e
Device Description
810X - CPRotector® - w/Nitrile Gloves - 2/Unit
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
- No
- 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 |
|---|---|---|---|---|
| CBP | Valve, non-rebreathing | Anesthesiology | 868.5870 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60657 | Non-rebreathing valve, single-use | A non-sterile device containing a one-way valve intended to be used to direct the flow of breathing gases, typically in a breathing circuit or between an oxygen mask and its reservoir bag, to prevent patient rebreathing of exhaled gases. The device is available in various designs and includes unidirectional valves made of various materials (e.g., silicone, rubber, metal, or mica sheets/discs) that typically open and close with each inspiration/expiration. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00766588160702 | GS1 |
Customer Contacts
- Phone
- +1(816)483-9090
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K960587 | 000 |