FDA UDI
In Commercial Distribution
🇺🇸 United States
First+Aid
DI: 00048341007029
·
Model: S SDDLR 0125 R03606 FAB [was S SDDLR 0125 R03606 FBB]
·
U.S. COTTON, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
125
Basic Information
- Brand Name
- First+Aid
- Primary DI
- 00048341007029
- Version / Model
- S SDDLR 0125 R03606 FAB [was S SDDLR 0125 R03606 FBB]
- Catalog Number
- S SDDLR 0125 R03606 FAB
- Company Name
- U.S. COTTON, LLC
- Labeler DUNS
- 932938897
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 125
- Record Status
- Published
- Publish Date
- 2020-02-28
- Public Version
- 3
- Public Version Date
- 2021-02-04
- Public Version Status
- Update
- Public Device Record Key
- 21b7146c-29e5-4e59-aae5-dcca18077bdc
Device Description
Cotton Swabs (125ct)
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| KXF | Applicator, Absorbent Tipped, Non-Sterile | General Hospital | 880.6025 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33722 | General-purpose absorbent tip applicator/swab, single-use | A hand-held manual device, also known as a cotton bud or swab, in the form of a stick with a single- or double-ended absorbent tip (e.g., cotton pledget), intended for cleaning or applying a substance (e.g., medication) to a superficial wound or body orifice, and/or to take specimens from a patient. It is not dedicated to a particular body area or orifice, and is intended for use in a healthcare setting and/or in the home. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10048341007026 | GS1 | Case | 36 | In Commercial Distribution | |
| Primary | 00048341007029 | GS1 | ||||
| Unit of Use | 10048341800122 | GS1 |
Customer Contacts
- Phone
- 1-800-321-1029
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store indoors under normal ambient conditions in sealed package