FDA UDI
In Commercial Distribution
🇺🇸 United States
Custom Medical Specialties, Inc.
DI: 00815849021815
·
Model: CMS-6025
·
CUSTOM ASSEMBLIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Custom Medical Specialties, Inc.
- Primary DI
- 00815849021815
- Version / Model
- CMS-6025
- Company Name
- CUSTOM ASSEMBLIES, INC.
- Labeler DUNS
- 948904735
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-11-21
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 3b58d1ae-9482-4024-b52f-f0b99e4b8339
Device Description
Absorbent Pad - Sterile
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
- 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 |
|---|---|---|---|---|
| FRL | Fiber, Medical, Absorbent | General Hospital | 880.5300 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61849 | Absorbent underpad, sterile | A sterile 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 or incontinence. It is intended to be used in the healthcare facility and in the home. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00815849021822 | GS1 | 25 | In Commercial Distribution | ||
| Primary | 00815849021815 | GS1 |