FDA UDI
In Commercial Distribution
🇺🇸 United States
Unflavored Oral Swab, For Professional and Hospital Use
DI: 00840117348813
·
Model: 1218
·
Dynarex Corporation
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
250
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Basic Information
- Brand Name
- Unflavored Oral Swab, For Professional and Hospital Use
- Primary DI
- 00840117348813
- Version / Model
- 1218
- Company Name
- Dynarex Corporation
- Labeler DUNS
- 008124539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 250
- Record Status
- Published
- Publish Date
- 2019-09-03
- Public Version
- 4
- Public Version Date
- 2026-01-29
- Public Version Status
- Update
- Public Device Record Key
- bdca70cb-d83a-433b-b5dd-fae2400b5b8b
Device Description
Individually Wrapped
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- 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 |
|---|---|---|---|---|
| KXF | Applicator, Absorbent Tipped, Non-Sterile | General Hospital | 880.6025 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48037 | Oral care swab | A device designed as a piece of non-treated, absorbent material on a wooden, paper, or plastic stick and intended to moisten and clean a patient's oral cavity to maintain normal mouth patency and hygiene. It is commonly used on intensive care and long-term care patients to administer moisture, mouthwash, or medications to improve the physical condition of the oral cavity and possibly help reduce the incidence of patient infection. It is typically applied to the patient by nursing staff in hospitals and institutions, or attendants in homecare settings. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840117348813 | GS1 | ||||
| Unit of Use | 00810180842563 | GS1 | ||||
| Package | 00840117348820 | GS1 | Case | 4 | In Commercial Distribution |