FDA UDI
In Commercial Distribution
🇺🇸 United States
EDOCS
DI: 00860007698200
·
Model: EDOCS 120B-21
·
Pacific Consolidated Industries LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EDOCS
- Primary DI
- 00860007698200
- Version / Model
- EDOCS 120B-21
- Catalog Number
- 793720-001
- Company Name
- Pacific Consolidated Industries LLC
- Labeler DUNS
- 120848411
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-05-08
- Public Version
- 1
- Public Version Date
- 2023-05-16
- Public Version Status
- New
- Public Device Record Key
- 467a4fdc-339c-41c0-b1a1-adcf844cb115
Device Description
EDOCS 120B-21 FINAL ASSEMBLY - 120 LPM AT 85 PSI, 60 LPM AT 2250 PSI, 208-240V/50-60 HZ
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
- Yes
- 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 |
|---|---|---|---|---|
| CAW | Generator, Oxygen, Portable | Anesthesiology | 868.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57850 | Bulk oxygen concentration system | A stationary assembly of mains electricity (AC-powered) devices designed to concentrate oxygen (O2) from ambient air and then deliver the concentrated O2, with purity of up to 99.5%, to the hospital medical gas supply system. It may produce high-purity O2 using pressure swinging adsorption (PSA) technology which processes air through internal molecular sieves having a large total surface area to separate nitrogen (N2) from the air. It typically consists of an air compressor, refrigeration dryer, water and oil separators, high pressure O2 pump and various storage tanks. The concentrated O2 is delivered via the medical gas supply system to the user and/or a gas cylinder filling station. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860007698200 | GS1 |
Customer Contacts
- Phone
- 9514790860
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K061414 | 000 |