FDA UDI
In Commercial Distribution
🇺🇸 United States
15mm Gas Sample Adaptor Kit
DI: B882900070
·
Model: 90007
·
Beyond Air, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- 15mm Gas Sample Adaptor Kit
- Primary DI
- B882900070
- Version / Model
- 90007
- 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
- 1
- Public Version Date
- 2022-08-12
- Public Version Status
- New
- Public Device Record Key
- de628e2d-43f2-4d4b-8694-dbf02c7d274d
Device Description
90007 is a kit containing two off-the-shelf components: - 1: (61920) 15M-15F 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 15mm-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 |
|---|---|---|---|---|
| 46319 | Nitric oxide delivery system, secondary | An assembly of devices dedicated to the short-term delivery of precise amounts of nitric oxide (NO), also known as nitrogen monoxide, to the respiratory tract of patients for the treatment of severe respiratory failure, particularly when a primary delivery system cannot be used (functions as a backup system). It typically includes a computerized main unit that delivers NO to gases that are to be breathed by the patient via a ventilator or other respiratory device/system and which also monitors this gaseous mixture, and tubing. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | B882900071 | HIBCC | Box | 10 | In Commercial Distribution | |
| Primary | B882900070 | HIBCC | ||||
| Package | B882900072 | HIBCC | Box | 12 | In Commercial Distribution |
Customer Contacts
- Phone
- 1-855-586-4359
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P200044 | 000 |