FDA UDI
In Commercial Distribution
🇺🇸 United States
Roscoe Medical
DI: 00815067013609
·
Model: X1PASP03
·
COMPASS HEALTH BRANDS CORP.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Roscoe Medical
- Primary DI
- 00815067013609
- Version / Model
- X1PASP03
- Company Name
- COMPASS HEALTH BRANDS CORP.
- Labeler DUNS
- 827221698
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-13
- Public Version
- 1
- Public Version Date
- 2025-08-21
- Public Version Status
- New
- Public Device Record Key
- 33bc618d-e2d1-47eb-bd30-02cd5dfcb9f4
Device Description
Bacteria Filter for ASP-ROSP
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
- Yes
- 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 |
|---|---|---|---|---|
| CAH | Filter, Bacterial, Breathing-Circuit | Anesthesiology | 868.5260 | 2 |
| JCX | Apparatus, Suction, Ward Use, Portable, Ac-Powered | General, Plastic Surgery | 878.4780 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47366 | Emergency airway clearance suction system, electric | A portable assembly of devices, which includes a non-surgical invasive component, intended to aspirate unwanted materials (e.g., fluids, secretions) from the airway typically during patient transport or an emergency situation (e.g., placed on a crash cart). It includes an electrically-powered suction pump, a collection container, and patient contact devices (e.g., handpiece/tip, mask), and typically also contains tubing and microbial/hydrophobic filters. The system is not intended for surgical use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00815067013609 | GS1 |
Customer Contacts
- Phone
- 800-376-7263
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K063448 | 000 |