FDA UDI
In Commercial Distribution
🇺🇸 United States
APLICARE
DI: 00618407611066
·
Model: APLS1106
·
MEDLINE INDUSTRIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
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Basic Information
- Brand Name
- APLICARE
- Primary DI
- 00618407611066
- Version / Model
- APLS1106
- Catalog Number
- APLS1106
- Company Name
- MEDLINE INDUSTRIES, INC.
- Labeler DUNS
- 025460908
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-21
- Public Version
- 2
- Public Version Date
- 2022-12-09
- Public Version Status
- Update
- Public Device Record Key
- 61c6ab54-6886-4097-8c57-354df54e3577
Device Description
SWABSTCK, BENZOIN TINCTURE, 1/PK, STRL
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
- 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 |
|---|---|---|---|---|
| NEC | Bandage, liquid, skin protectant | General Hospital | 880.5090 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58979 | Synthetic-polymer liquid barrier dressing, sterile | A sterile liquid preparation composed of synthetic polymer materials intended to form a thin protective film when applied to superficial wounds (e.g., minor cuts, abrasions) and/or intact skin (typically sensitive areas such as around a stoma), to reduce exposure to external contaminants; may also be intended to augment the adherence of medical adhesives, or provide a protective interface when removing medical adhesives. It may be presented as a wipe, swab, or spray. After application, this device cannot be reused. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00618407611066 | GS1 | ||||
| Package | 20618407611060 | GS1 | CS | 500 | In Commercial Distribution | |
| Package | 30618407611067 | GS1 | MC | 1000 | In Commercial Distribution | |
| Package | 10618407611063 | GS1 | BX | 50 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(800)633-5463
- [email protected]