FDA UDI
In Commercial Distribution
🇺🇸 United States
DRIVEMEDICAL
DI: 00822383269986
·
Model: WB 8021
·
Drive Devilbiss Healthcare
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DRIVEMEDICAL
- Primary DI
- 00822383269986
- Version / Model
- WB 8021
- Company Name
- Drive Devilbiss Healthcare
- Labeler DUNS
- 867673159
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-19
- Public Version
- 3
- Public Version Date
- 2019-07-15
- Public Version Status
- Update
- Public Device Record Key
- 6cef16a3-3202-457a-a908-e16a0cc72fb9
Device Description
RespiratoryRespiratory Disposables Product Description: No-kink oxygen tubing 50 feet, 20/cs
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
- Yes
- 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 |
|---|---|---|---|---|
| BYX | TUBING, PRESSURE AND ACCESSORIES | Anesthesiology | 868.5860 | 1 |
| CAT | CANNULA, NASAL, OXYGEN | Anesthesiology | 868.5340 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61833 | Inspiratory/expiratory limb respiratory tubing, reusable | A length of tube made of durable materials (e.g., rubber, silicone) intended to be used to conduct breathing gases towards or away from a patient during the respiratory cycle, typically during anaesthesia or ventilation [including continuous or bi-level positive airway pressure ventilation (CPAP or BPAP)]. It is intended to function as part of a breathing circuit and with other separate gas delivery devices (e.g., respiratory mask, connectors). This is a reusable device intended to be cleaned/disinfected prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00822383269986 | GS1 |