FDA UDI
In Commercial Distribution
🇺🇸 United States
ProCure
DI: 10840330705872
·
Model: PCHCB002L
·
Twin Med, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- ProCure
- Primary DI
- 10840330705872
- Version / Model
- PCHCB002L
- Catalog Number
- PCHCB002L
- Company Name
- Twin Med, LLC
- Labeler DUNS
- 107071289
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-11-26
- Public Version
- 2
- Public Version Date
- 2026-04-07
- Public Version Status
- Update
- Public Device Record Key
- d3870f66-0927-48c9-b372-e097c722c4ac
Device Description
ProCure Healing Two Layer Lite Compression Bandage System Kit 45bx/cs
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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FQM | Bandage, Elastic | General Hospital | 880.5075 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58983 | Compression bandaging kit | A collection of various types of bandages intended for use in the treatment of venous leg ulcers, and related conditions, by sequential bandage application to provide graduated ascending-decreasing compression from the ankle to the knee. Typically the bandages are applied in a sequence of layers: a padding/exudate absorbing layer (e.g., polyester), a retention layer (e.g., cotton/polyester/elastane), a compression layer (e.g., viscose/polyester covered elastane) and a self-adherent compression/outer retention layer (e.g., latex/polyester/elastane). It is intended to be applied by a healthcare professional for use in the home and healthcare facility. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30840330705876 | GS1 | Case | 45 | In Commercial Distribution | |
| Primary | 10840330705872 | GS1 |
Customer Contacts
- Phone
- 804-776-2873
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 10 | Centimeter | |
| Length | 5 | Meter | |
| Length | 3.5 | Meter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 40 – Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 80 – Percent (%) Relative Humidity