FDA UDI
In Commercial Distribution
🇺🇸 United States
Allied Healthcare Products, Inc.
DI: 00026072000076
·
Model: AHP300-ISO
·
ALLIED HEALTHCARE PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Allied Healthcare Products, Inc.
- Primary DI
- 00026072000076
- Version / Model
- AHP300-ISO
- Catalog Number
- AHP300-ISO
- Company Name
- ALLIED HEALTHCARE PRODUCTS, INC.
- Labeler DUNS
- 099674145
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-11-20
- Public Version
- 4
- Public Version Date
- 2020-01-13
- Public Version Status
- Update
- Public Device Record Key
- f9cc55fa-65b8-4d06-b333-549497512a4d
Device Description
Transport ventilator with internal compressor.
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
- Yes
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| BTL | Ventilator, Emergency, Powered (Resuscitator) | Anesthesiology | 868.5925 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36289 | Transport electric ventilator | An electrically-powered device designed to provide automated, alveolar ventilatory support for patients during interhospital or intrahospital transport, and in emergency situations. It is typically a compact, lightweight, rugged device with internal batteries to power it during patient transport. It typically provides mandatory breaths at pre-set intervals (control mode), not allowing the patient to breathe spontaneously; operation in assist/control and/or synchronized intermittent mandatory ventilation (SIMV) modes is available in some types. It usually includes an airway pressure monitor and low and high pressure alarms; it may be used in ambulances, and in field hospitals. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00026072000076 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K132021 | 000 |