FDA UDI
In Commercial Distribution
🇺🇸 United States
BioButton Rechargeable Adhesives
DI: 00850005949237
·
Model: ACCS-1-ST06-1-4
·
BIOINTELLISENSE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
1
Basic Information
- Brand Name
- BioButton Rechargeable Adhesives
- Primary DI
- 00850005949237
- Version / Model
- ACCS-1-ST06-1-4
- Catalog Number
- N/A
- Company Name
- BIOINTELLISENSE, INC.
- Labeler DUNS
- 116984478
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-03-01
- Public Version
- 3
- Public Version Date
- 2022-07-04
- Public Version Status
- Update
- Public Device Record Key
- f5a74b41-9586-4fae-8eb4-4e75433df6d6
Device Description
Adhesive accessory packs for wearable devices (OMI, ADB); ACCS-1-ST06-1-4
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KGX | Tape And Bandage, Adhesive | General Hospital | 880.5240 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16866 | Dressing-fixation skin adhesive tape, non-silicone | A long and narrow flexible band of non-silicone-based material (e.g., fabric, plastic, paper) coated on one or both sides with a pressure-sensitive adhesive, intended to non-invasively adhere to the skin surface to fix a dressing in place or attach objects (e.g., catheter, lamp); it might have hypoallergenic and/or waterproof properties. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10850005949234 | GS1 | 50-pack Inner Carton | 50 | In Commercial Distribution | |
| Primary | 00850005949237 | GS1 | ||||
| Package | 30850005949238 | GS1 | 2-pack Inner Carton | 2 | In Commercial Distribution | |
| Package | 20850005949231 | GS1 | 6-box Master Carton | 6 | In Commercial Distribution | |
| Package | 40850005949235 | GS1 | 100-mailer Master Ca | 100 | In Commercial Distribution |