FDA UDI
In Commercial Distribution
🇺🇸 United States
DropSafe™ Inject-Safe Barrier Bandage™
DI: 05907996099979
·
Model: n/a
·
HTL STREFA S A
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
Basic Information
- Brand Name
- DropSafe™ Inject-Safe Barrier Bandage™
- Primary DI
- 05907996099979
- Version / Model
- n/a
- Catalog Number
- 6070
- Company Name
- HTL STREFA S A
- Labeler DUNS
- 422528088
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2023-06-25
- Public Version
- 1
- Public Version Date
- 2023-07-03
- Public Version Status
- New
- Public Device Record Key
- f25435b0-0849-490a-8ac8-9dd463d4b0b5
Device Description
Barrier Bandage it’s intended to contain post-injection bleeding during a subcutaneous or intramuscular injection. The device is intended for healthcare professions (HCP) and lay users. The device is an OTC product.
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 |
|---|---|---|---|---|
| KGX | Tape And Bandage, Adhesive | General Hospital | 880.5240 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65285 | Skin adhesive protective material | A liquid preparation designed to be applied evenly over intact skin to form a synthetic polymer film, prior to application of an adhesive strip/bandage, to protect the skin during subsequent removal of the adhesive strip/bandage. It may be presented as a wipe/swab. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 15907996099976 | GS1 | shipper box | 20 | In Commercial Distribution | |
| Primary | 05907996099979 | GS1 | ||||
| Unit of Use | 85907996099975 | GS1 |