FDA UDI
In Commercial Distribution
🇺🇸 United States
Ventlab
DI: 10889483105375
·
Model: FH603003CFF
·
VENTLAB, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Ventlab
- Primary DI
- 10889483105375
- Version / Model
- FH603003CFF
- Company Name
- VENTLAB, LLC
- Labeler DUNS
- 038305402
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-11
- Public Version
- 3
- Public Version Date
- 2020-09-22
- Public Version Status
- Update
- Public Device Record Key
- 691673a5-2995-40b6-b735-3a7b9d8ec0f1
Device Description
Bacterial/Viral Filter w/ 22mm Cuff
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
- 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 |
|---|---|---|---|---|
| CAH | Filter, Bacterial, Breathing-Circuit | Anesthesiology | 868.5260 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60837 | Microbial medical gas filter, single-use | A screening device intended to remove microbes from medical gases to prevent patient exposure during respiration, anaesthesia and/or endoscopy; it has no additional non-filtering functions. It is a small plastic housing containing a filter which will typically also filter other particulates (e.g., scale). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20889483105372 | GS1 | Box | 50 | In Commercial Distribution | |
| Primary | 10889483105375 | GS1 |
Customer Contacts
- Phone
- 800-433-2797
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 22 | Millimeter | |
| Lumen/Inner Diameter | 15 | Millimeter | |
| Lumen/Inner Diameter | 22 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- General Warehouse. Do not get wet.