FDA UDI
In Commercial Distribution
🇺🇸 United States
Blueline
DI: 00199536911017
·
Model: 676105
·
Transparent Supply Solutions Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Blueline
- Primary DI
- 00199536911017
- Version / Model
- 676105
- Catalog Number
- 676105
- Company Name
- Transparent Supply Solutions Ltd.
- Labeler DUNS
- 119522714
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-09-22
- Public Version
- 1
- Public Version Date
- 2025-09-30
- Public Version Status
- New
- Public Device Record Key
- f0a128bf-12ab-4ccb-ba36-600c681b2ddf
Device Description
Basic Fluff Underpad, 23"x36", Light Absorbency
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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EYQ | Garment, Protective, For Incontinence | Gastroenterology, Urology | 876.5920 | 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 |
|---|---|---|---|---|---|---|
| Primary | 00199536911017 | GS1 | ||||
| Package | 30199536911018 | GS1 | PACK | 10 | In Commercial Distribution | |
| Package | 50199536911012 | GS1 | CASE | 15 | In Commercial Distribution |