FDA UDI
In Commercial Distribution
🇺🇸 United States
FORWARD APLS Surgery Soaker
DI: 00850056748315
·
Model: CPV-2854-1
·
INTEGRATED MEDCRAFT LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- FORWARD APLS Surgery Soaker
- Primary DI
- 00850056748315
- Version / Model
- CPV-2854-1
- Company Name
- INTEGRATED MEDCRAFT LLC
- Labeler DUNS
- 107523667
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-11-06
- Public Version
- 1
- Public Version Date
- 2025-11-14
- Public Version Status
- New
- Public Device Record Key
- 36257aac-f324-4afa-b937-1ca3af847d4f
Device Description
A disposable absorbent pad that contains blood, bodily fluids and solutions under operating room tables in all military and civilian medical environments. Constructed with a highly absorbent core and poly backing, APLS Surgery Soaker is the safe way to maintain dry and clean conditions in all medical environments.
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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FMW | Cover, Mattress (Medical Purposes) | General Hospital | 880.6190 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61850 | Absorbent underpad, non-antimicrobial, single-use | A flat piece of absorbent fabric material [e.g., non-woven polyethylene (PE), cellulose] intended to be placed on a surface (e.g., bed mattress, table, floor) and underneath a patient to absorb bodily fluids resulting from surgical procedures, childbirth and/or incontinence; it does not include an antimicrobial agent(s). It is intended to be used in the healthcare facility and in the home. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00850056748308 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 00850056748315 | GS1 |