FDA UDI
In Commercial Distribution
🇺🇸 United States
Gold Edition O2 Analyzer
DI: 00850644007015
·
Model: 17518
·
Vacumed
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Gold Edition O2 Analyzer
- Primary DI
- 00850644007015
- Version / Model
- 17518
- Catalog Number
- 17518
- Company Name
- Vacumed
- Labeler DUNS
- 077967081
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-14
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 2aac4af8-ff4c-47fd-89ed-02e2af61953e
Device Description
O2 Analyzer
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| CCL | ANALYZER, GAS, OXYGEN, GASEOUS-PHASE | Anesthesiology | 868.1720 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15015 | Oxygen breath analyser | A mains electricity (AC-powered) laboratory instrument designed for intermittent/periodic measurements of oxygen (O2) content in a breath and/or respiratory gas specimen. It usually requires manual aspiration of a quantity of gas into a sampling chamber and may operate according to one of several basic principles (e.g., paramagnetism, polarography). The device is used in pulmonary function tests and for measurements in critically ill patients, such as infants in incubators and patients breathing air with supplemental oxygen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850644007015 | GS1 |
Customer Contacts
- Phone
- +1(800)235-3333
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K973545 | 000 |