FDA UDI
In Commercial Distribution
🇺🇸 United States
Equaline
DI: 00041163417618
·
Model: 041163417618
·
SUPERVALU INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
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Basic Information
- Brand Name
- Equaline
- Primary DI
- 00041163417618
- Version / Model
- 041163417618
- Company Name
- SUPERVALU INC.
- Labeler DUNS
- 006961411
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2020-05-29
- Public Version
- 3
- Public Version Date
- 2020-08-07
- Public Version Status
- Update
- Public Device Record Key
- 07ccb5b4-ba0b-418f-86ec-cd20e4936dbf
Device Description
Extra Large Heavy Duty Strong Strips Adhesive Bandages, 1.75 in x 4 in (44 mm x 101 mm)
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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KGX | Tape And Bandage, Adhesive | General Hospital | 880.5240 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44990 | Skin-cover adhesive strip, non-antimicrobial | A small, narrow, flexible band (of fabric, plastic, paper, or other material) coated on one side with a pressure-sensitive adhesive and possibly with an absorbent pad, typically intended to cover a superficial wound or fix a dressing to skin. It may be hypoallergenic and/or waterproof, however it does not include antimicrobial agents/properties. Commonly referred to as a sticking plaster, it is intended for use in the home or a clinical setting. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10041163417615 | GS1 | case | 24 | In Commercial Distribution | |
| Primary | 00041163417618 | GS1 | ||||
| Unit of Use | 60041163417610 | GS1 |
Customer Contacts
- Phone
- 18779327948
- [email protected]