FDA UDI
In Commercial Distribution
🇺🇸 United States
22mm Gas Sample Adaptor Kit
DI: B882900170
·
Model: 90017
·
Beyond Air, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- 22mm Gas Sample Adaptor Kit
- Primary DI
- B882900170
- Version / Model
- 90017
- Company Name
- Beyond Air, Inc.
- Labeler DUNS
- 080243711
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-04
- Public Version
- 2
- Public Version Date
- 2025-02-14
- Public Version Status
- Update
- Public Device Record Key
- 36b48649-4df2-49a3-8cf7-5ecd38690ca8
Device Description
90017 is a kit containing two off-the-shelf components: - 1: (61928) 22M-22F Straight Connector with 7.6 mm Port - 2: (61921) Luer Elbow, fits 7.6 mm Port The two pieces fit together to provide a sampling port which fits on a 22mm-diameter breathing circuit.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QTB | Nitric Oxide Generator And Delivery System | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37266 | Nitric oxide delivery unit, system-based | A mains electricity (AC-powered) device, which may include internal rechargeable batteries, intended for the delivery of precise amounts of nitric oxide (NO), also known as nitrogen monoxide, to the respiratory tract of neonate, paediatric, and adult patients to treat severe respiratory disorders [e.g., primary pulmonary hypertension (PPH), acute respiratory distress syndrome (ARDS)]. It consists of a portable main unit that enables the delivery and monitoring of NO to gases that are to be breathed by the patient via a ventilator or other respiratory device/system. It typically includes accessory items (e.g., tubing, filters) and possibly a trolley (cart) for mobility. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | B882900171 | HIBCC | Box | 10 | In Commercial Distribution | |
| Primary | B882900170 | HIBCC | ||||
| Package | B882900172 | HIBCC | Box | 12 | In Commercial Distribution |
Customer Contacts
- Phone
- 1-855-586-4359
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P200044 | 000 |