FDA UDI
In Commercial Distribution
🇺🇸 United States
Dynamic Gas Scavenging System
DI: 00863573000408
·
Model: DGSS - 2
·
Anesthetic Gas Reclamation, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Dynamic Gas Scavenging System
- Primary DI
- 00863573000408
- Version / Model
- DGSS - 2
- Company Name
- Anesthetic Gas Reclamation, LLC
- Labeler DUNS
- 023784203
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-05-03
- Public Version
- 1
- Public Version Date
- 2023-05-11
- Public Version Status
- New
- Public Device Record Key
- a9d7c5bf-9d1b-4d3c-ac6d-4e59b66d7b6d
Device Description
Waste anesthetic gas (WAG) scavenging interface for anesthesia delivery machines which replaces the active or passive scavenging interface with a more efficient "closed" unit. Made in USA
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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Primary | 00863573000408 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K193646 | 000 |