FDA UDI
In Commercial Distribution
🇺🇸 United States
MUC-X
DI: H671IM71010FR0
·
Model: 10 French
·
UTAH MEDICAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- MUC-X
- Primary DI
- H671IM71010FR0
- Version / Model
- 10 French
- Catalog Number
- IM71010FR
- Company Name
- UTAH MEDICAL PRODUCTS, INC.
- Labeler DUNS
- 094651270
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-04
- Public Version
- 1
- Public Version Date
- 2020-06-12
- Public Version Status
- New
- Public Device Record Key
- 78f6b7fc-f9d0-42f2-ae7e-22348c262b49
Device Description
MUC-X 10FR MUCOUS TRAP W/ WALL SUCTION ADAPTOR
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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BSY | Catheters, Suction, Tracheobronchial | Anesthesiology | 868.6810 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62605 | ENT surgical aspirator | A sterile hand-held device intended to be used to aspirate fluid from a ENT cavity (e.g., middle ear) during a single surgical procedure. It typically consists of a flexible tube inserted into the cavity, a collection container and a connection to the wall outlet of a central vacuum system. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | H671IM71010FR0 | HIBCC | ||||
| Package | H671IM71010FR1 | HIBCC | 25 | In Commercial Distribution |
Customer Contacts
- Phone
- 800-533-4984
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K893204 | 000 |