FDA UDI
In Commercial Distribution
🇺🇸 United States
DALTON ASPIRATOR
DI: 00815027011850
·
Model: ASP
·
DALTON MEDICAL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DALTON ASPIRATOR
- Primary DI
- 00815027011850
- Version / Model
- ASP
- Company Name
- DALTON MEDICAL CORPORATION
- Labeler DUNS
- 874709348
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-12-31
- Public Version
- 1
- Public Version Date
- 2021-01-08
- Public Version Status
- New
- Public Device Record Key
- 867dcb32-f471-44ea-a915-bc83471de071
Device Description
ASPIRATOR, SUCTION DEVICE WITHOUT CANISTER.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| JCX | Apparatus, Suction, Ward Use, Portable, Ac-Powered | General, Plastic Surgery | 878.4780 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34975 | Cricothyrotome, reusable | A hand-held manual surgical instrument intended to be used to perform a cricothyrotomy (an incision through the skin and cricothyroid) providing airway access within seconds for immediate ventilation of the patient and necessary suction procedures. It is used to open a patient's airway in emergency interventions, e.g., accidental blockage of the upper airway tract, and prior to tracheotomy. It is made of high-grade stainless steel and plastic materials. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00815027011850 | GS1 |