FDA UDI
In Commercial Distribution
🇺🇸 United States
AirStrip ONE Client iOS
DI: B153301010
·
Model: 30101
·
Airstrip Technologies, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- AirStrip ONE Client iOS
- Primary DI
- B153301010
- Version / Model
- 30101
- Company Name
- Airstrip Technologies, Inc.
- Labeler DUNS
- 079232437
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-18
- Public Version
- 1
- Public Version Date
- 2026-03-26
- Public Version Status
- New
- Public Device Record Key
- 2ad44bf3-0655-4d73-bcd3-4f7c67f4da3e
Device Description
AirStrip Cardiology, Patient Monitoring and OB - Client iOS
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| HGM | System, Monitoring, Perinatal | Obstetrics/Gynecology | 884.2740 | 2 |
| MWI | Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms) | Cardiovascular | 870.2300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66386 | Bedside monitor remote-viewing software, physiological parameter | An application software program intended to be installed on a non-medical off-the-shelf device (e.g., computer/smartphone/tablet) to allow a healthcare professional to view real-time and historical patient physiologic data [e.g., electrocardiogram (ECG), blood pressure, heart rate, SpO2] from bedside monitors via data transmission through a centralized patient monitor or data network server. It is designed for viewing data only as a remote or telemedicine application (e.g., in a hospital patient monitoring room, or clinician’s office) intended to support, and not replace, standard patient monitoring. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B153301010 | HIBCC | ||||
| Previous | B15320010 | HIBCC |
Customer Contacts
- Phone
- 1-877-258-5869
- [email protected]