M-Brace Air
Basic Information
- Brand Name
- M-Brace Air
- Primary DI
- 05391512284336
- Version / Model
- 515 XXL
- Catalog Number
- 515
- Company Name
- INDACO SRL
- Labeler DUNS
- 338470646
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-22
- Public Version
- 1
- Public Version Date
- 2024-03-01
- Public Version Status
- New
- Public Device Record Key
- e48c6906-a4f5-4278-a4a7-c2748cf25083
Device Description
This abdominal binder belt brace was designed to provide abdominal content containment, particularly during early patient mobilization after abdominal surgery. It provides hernia support, back pain relief, obesity-related discomfort, weak abdominal muscle support and is very effective to help with post-pregnancy abdominal support. This binder is available in a wide range of sizes up to 55-inch circumference and is 10.2 inches in height. It is made with two wide panels providing an innovative locking system based on twin crisscrossing straps that offer an easy fit for all different shapes and sizes. Easy to put and adjustable for a comfortable fit. Made with the patient in mind, with super soft natural materials, 85% Cotton,and 15% Elastane. Made in Italy. Benefits: 24H COMFORT, SUPER SLIM, BREATHABLE, ULTRA LIGHT, EASY TO USE, WASHABLE, WATER WICKING FIBERS, TWO WIDE PANEL STRAPS, ADJUSTABLE COMPRESSION. INDICATIONS Umbilical Hernia Post Pregnancy Abdomen Support Hernia Support Back Support Abdomen Injury Post Surgery Support General Abdomen Containment
Device Characteristics
- Single Use
- No
- 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
- 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 |
|---|---|---|---|---|
| FSD | Binder, Abdominal | General Hospital | 880.5160 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47217 | Abdominal binder, reusable | A strip, roll or tube of fabric or polymer material intended to be applied to the abdomen to support relaxed abdominal walls (e.g., after surgery, during pregnancy) or to provide support for another device (e.g., dressing, ultrasound transducer, percutaneous lead). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05391512286514 | GS1 | Box Case | 10 | In Commercial Distribution | |
| Primary | 05391512284336 | GS1 |
Customer Contacts
- Phone
- 866-374-4050
- [email protected]