FDA UDI
In Commercial Distribution
🇺🇸 United States
AP Onkers
DI: 00815090013409
·
Model: 16-7
·
SMALL BEGINNINGS INC
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
5
Basic Information
- Brand Name
- AP Onkers
- Primary DI
- 00815090013409
- Version / Model
- 16-7
- Catalog Number
- 16-7
- Company Name
- SMALL BEGINNINGS INC
- Labeler DUNS
- 002657679
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2022-12-15
- Public Version
- 1
- Public Version Date
- 2022-12-23
- Public Version Status
- New
- Public Device Record Key
- 8e0c2235-344d-4293-8fc5-bee45415571d
Device Description
Adult/Pediatric oral/nasal suction device.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | General Hospital | 880.6740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34883 | Airway device cleaning utensil, noninvasive, reusable | A hand-held device intended to be used to clean an ex situ non-endoscopic airway device [e.g., endotracheal (ET) tube, tracheoesophageal speech valve, laryngeal airway], once it has been removed from the patient, to remove organic matter (e.g., phlegm). It is in the form of a flexible or rigid handle with distal soft or stiff bristles, fibres or spines, or a swab; it may be used in the home or healthcare facility. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10815090013406 | GS1 | Box | 100 | In Commercial Distribution | |
| Primary | 00815090013409 | GS1 | ||||
| Package | 20815090013403 | GS1 | Case | 600 | In Commercial Distribution | |
| Unit of Use | 00815090013416 | GS1 |
Customer Contacts
- Phone
- 760-949-7707
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 18 | Centimeter |