RespVent™
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- RespVent™
- Primary DI
- 00850108006103
- Version / Model
- RTG-01101
- Catalog Number
- RTG-01101
- Company Name
- CUTTING EDGE HC BRANDS LLC
- Labeler DUNS
- 080216804
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 5
- Public Version Date
- 2024-02-05
- Public Version Status
- Update
- Public Device Record Key
- 0bac754a-f009-458f-becc-deabbd19934f
Device Description
RespVent HEPA Bacteria Viral Respiratory Filter is a disposable single-use device indicated for patient during the delivery of ventilator gases. They provide filtration for reducing possible cross contamination between patient and equipment. The RespVent Filter is for use in hospital, ICU, anesthesia, respiratory therapy, during transport and with resuscitators. The RespVent Filter can be used on adult patients. The RespVent Filter is indicated for use by qualified medical personnel only. The RespVent Filter is designed for disposable use and should be changed at least every 24 hours.
Device Characteristics
- Single Use
- Yes
- 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
- 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
- No
- 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 |
|---|---|---|---|---|
| CAH | Filter, Bacterial, Breathing-Circuit | Anesthesiology | 868.5260 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37597 | Heat/moisture exchanger insertable filter | A dedicated membrane that is inserted into a reusable heat & moisture exchanger (HME) to capture a patient's exhaled heat and moisture, so that they can be used to heat and humidify therapeutic gases inspired by the patient typically during anaesthesia or intensive care ventilation. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10850108006100 | GS1 | Carton | 25 | In Commercial Distribution | |
| Primary | 00850108006103 | GS1 |
Customer Contacts
- Phone
- 9999999999
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 33 | Gram | |
| Device Size Text, specify | Connections: 22M/15F-22F/15M |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a clean, cool, dry place in original wrapper. Shelf life: Max. 3 years.