FDA UDI
In Commercial Distribution
🇺🇸 United States
Rescuer
DI: B0024000F0
·
Model: 4000F
·
B.L.S. Systems Limited
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Rescuer
- Primary DI
- B0024000F0
- Version / Model
- 4000F
- Catalog Number
- 4000F
- Company Name
- B.L.S. Systems Limited
- Labeler DUNS
- 200103823
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-01-08
- Public Version
- 3
- Public Version Date
- 2024-04-04
- Public Version Status
- Update
- Public Device Record Key
- f85d23bf-ec2d-4b84-9dc1-b4cf7752945c
Device Description
HEPA Filter component for Rescuer BVM Manual Resuscitator (Emergency Manual Ventilator)
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
- 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
- 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 |
|---|---|---|---|---|---|---|
| Primary | B0024000F0 | HIBCC | ||||
| Package | B0024000F2 | HIBCC | Bag | 10 | In Commercial Distribution | |
| Package | B0024000F3 | HIBCC | Bag | 12 | In Commercial Distribution |
Customer Contacts
- Phone
- 19053391069
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K993194 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 50 Degrees Celsius