Areza Medical
Basic Information
- Brand Name
- Areza Medical
- Primary DI
- 00850021481766
- Version / Model
- RT4X11
- Catalog Number
- RT4X11
- Company Name
- ADVANCED MEDICAL ASSOCIATES, LLC
- Labeler DUNS
- 047724226
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-11-07
- Public Version
- 1
- Public Version Date
- 2024-11-15
- Public Version Status
- New
- Public Device Record Key
- 66fc2faa-9a70-4cff-b167-6ff7a8b249fa
Device Description
Areza Medical's Retention Tape is ideal for securing medical devices, dressings, and tubes in place, preventing unwanted movement or displacement. Our Retention Tape is versatile and can be used on various body parts, including the abdomen, arms, and legs, ensuring a secure and comfortable fit. Areza Medical's Retention Tape is designed with a strong adhesive that securely sticks to the skin, yet it is gentle enough to be easily removed. The tape's breathable material allows for airflow and moisture evaporation. Our Retention Tape is latex-free, making it suitable for individuals with allergies or sensitivities to latex. This tape is crafted from polyester non-woven material covered with medical grade glue on the adhesive side and waterproof PU film on the outside.
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
- 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 |
|---|---|---|---|---|---|---|
| Primary | 00850021481766 | GS1 | ||||
| Package | 00810147401734 | GS1 | Inner case | 8 | In Commercial Distribution | |
| Package | 00810147401741 | GS1 | Case | 48 | In Commercial Distribution |
Customer Contacts
- Phone
- (214) 356-8716
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 4 | Inch | |
| Length | 11 | Yard |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a cool, dry place. Avoid excessive heat