FDA UDI
In Commercial Distribution
🇺🇸 United States
Premier Evacuator 110V Air Filtration System
DI: D69190063000
·
Model: 9006300
·
DERMATOLOGIC LAB AND SUPPLY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Premier Evacuator 110V Air Filtration System
- Primary DI
- D69190063000
- Version / Model
- 9006300
- Catalog Number
- 9006300
- Company Name
- DERMATOLOGIC LAB AND SUPPLY, INC.
- Labeler DUNS
- 021628771
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-07-10
- Public Version
- 1
- Public Version Date
- 2018-08-10
- Public Version Status
- New
- Public Device Record Key
- 79de56a8-a55b-4033-bc8f-f29a3621ff4f
Device Description
Premier Evacuator 110V Air Filtration System. Contains one Premier Evacuator 110V unit, one detachable cord, and Disposable Filter Pack (5 filters - reorder number 9006290).
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 |
|---|---|---|---|---|
| FYD | Apparatus, Exhaust, Surgical | General, Plastic Surgery | 878.5070 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37861 | Surgical plume evacuation system | A mains electricity (AC-powered) assembly of devices intended to capture smoke generated during open surgical procedures involving tissue ablation (e.g., laser surgery, electrocautery, electrosurgical diathermy device). It captures the plume (smoke composed of carbonized cell fragments, water vapour, and hydrocarbons from vaporized tissue) near its origin before it becomes dispersed and causes surgical staff respiratory exposure. It consists of a capture tube or wand and four elements to evacuate smoke: user interface, filters, suction source, and exhaust. The system may be mobile (on wheels) and used during closed surgical procedures (e.g., endoscopy, laparoscopy) to clear the view. See also: Gas/fume evacuation system; Anaesthetic gas scavenging unit; Suction system filter, plume particulate; Orthopaedic cement fume evacuator; Surgical plume evacuation system tube | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D69190063000 | HIBCC |