FDA UDI
In Commercial Distribution
🇺🇸 United States
Responsive Respiratory, Inc.
DI: 00851440007520
·
Model: 220-1571
·
RESPONSIVE RESPIRATORY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Responsive Respiratory, Inc.
- Primary DI
- 00851440007520
- Version / Model
- 220-1571
- Company Name
- RESPONSIVE RESPIRATORY, INC.
- Labeler DUNS
- 129132747
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-10
- Public Version
- 1
- Public Version Date
- 2023-06-19
- Public Version Status
- New
- Public Device Record Key
- a4fefcd0-c44b-4fc5-b588-feb37bceb723
Device Description
Y Tubing Connector
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| BYX | Tubing, Pressure And Accessories | Anesthesiology | 868.5860 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61166 | Inhalation-therapy adaptor, single-use | A connecting device, usually with a small channel or tubing, intended to join a water/saline pack or a noninvasive ventilation respiratory unit to an inhalation therapy device (e.g., humidifier, vibrating mesh nebulizer, oxygen therapy delivery system). It may be used when the connection is compatible (e.g., when the connected devices are of the same manufacture) or when incompatible (e.g., different manufacture). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00851440007520 | GS1 |