Device
ProCure Foam - Waterproof Foam Dressing w/Border 4"x4" 10ea/bx 40bx/cs
Manufacturer
Twin Med, LLC
Model: PCHF3005 Catalog: PCHF3005 DI: 10840330706695 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: Yes Rx: No OTC: Yes
First Published: 2026-05-07 Current Version: 2026-05-15
Description
ProCure Foam - Waterproof Foam Dressing w/Border 4"x4" 10ea/bx 40bx/cs
Sterilization
Device Sterile: Yes
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: be82de79-3f15-45f0-8948-1908bf8a6b2e
Distribution Status: In Commercial Distribution
DUNS Number: 107071289
Device Count: 1
DM Exempt: No
Premarket Exempt: Yes
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: Yes
Serial Number Tracked: No
Manufacturing Date Tracked: Yes
Expiration Date Tracked: Yes
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: Yes
Identifiers
Item #1 - Pkg Type: Box
Item #1 - Device ID: 30840330706699
Item #1 - Pkg Status: In Commercial Distribution
Item #1 - Pkg Quantity: 10
Item #1 - Device ID Type: Package
Item #1 - Contains DINumber: 10840330706695
Item #1 - Device ID Issuing Agency: GS1
Item #2 - Device ID: 10840330706695
Item #2 - Device ID Type: Primary
Item #2 - Device ID Issuing Agency: GS1
GMDN
Code: 44970
Name: Exudate-absorbent dressing, non-gel, non-antimicrobial
Definition:
A wound covering intended to assist in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) and often by creating a moist wound-healing environment. It is not in the form of a gel and does not produce a water-absorbent gel upon contact with wound exudates, but may be designed to absorb and remove exudates (e.g., by capillary action); it does not contain an antimicrobial agent, but may include antioxidant properties. The device is available in a variety of forms (e.g., flat sheet/film-like, impregnated pouches, filled sachets, lyophilized matrix, ribbon, rope, foam, liquid, or powder). After application, this device cannot be reused.
FDA Product Codes
NAD
Dressing, Wound, Occlusive
Device Sizes
Item #1 - Size - @attributes - Unit: Centimeter
Item #1 - Size - @attributes - Value: 10
Item #1 - Size Type: Length
Item #2 - Size - @attributes - Unit: Centimeter
Item #2 - Size - @attributes - Value: 10
Item #2 - Size Type: Width
Item #3 - Size Text: Pad is 6 cm by 6 cm
Item #3 - Size Type: Device Size Text, specify
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit: Degrees Fahrenheit
Item #1 - Storage Handling High - @attributes - Unit: Degrees Fahrenheit
Item #1 - Storage Handling High - @attributes - Value: 104
Item #1 - Storage Handling Type: Storage Environment Temperature
Item #2 - Storage Handling Type: Special Storage Condition, Specify
Item #2 - Storage Handling Special Condition Text: Store in a sealed, cool and dry place avoiding light and under 40 C/ 104 F