FDA UDI
In Commercial Distribution
🇺🇸 United States
ANEclear
DI: 00863034000329
·
Model: 2
·
ANECARE, LLC
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- ANEclear
- Primary DI
- 00863034000329
- Version / Model
- 2
- Catalog Number
- 90020
- Company Name
- ANECARE, LLC
- Labeler DUNS
- 824640226
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-02-27
- Public Version
- 2
- Public Version Date
- 2018-07-06
- Public Version Status
- New
- Public Device Record Key
- f3124d40-d5cd-48f9-bb4c-6ce48fa33cea
Device Description
Anesthesia Recovery Device
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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 |
|---|---|---|---|---|
| BYW | Device, Rebreathing | Anesthesiology | 868.5675 | 1 |
| CBN | Apparatus, Gas-Scavenging | Anesthesiology | 868.5430 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34849 | Anaesthesia workstation gas scavenger | A pneumatically-powered device that is a component of an anaesthesia workstation and connects between the expiratory valve or port of a breathing circuit and the extraction system enabling the waste anaesthetic, exhaled, or other trace gasses to be removed under controlled conditions from the work environment and channelled to the outside of the building. Filters or absorbers may be required to clean the removed gasses before discharging to the atmosphere. This device is also known as an anaesthetic gas scavenging system (AGSS). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10863034000326 | GS1 | Case | 20 | In Commercial Distribution | |
| Primary | 00863034000329 | GS1 |
Customer Contacts
- Phone
- 801-977-8877
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K033028 | 000 |