FDA UDI
In Commercial Distribution
🇺🇸 United States
ManaMed
DI: 00810113680880
·
Model: Kangaroo Shoulder Sling
·
MANAMED INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ManaMed
- Primary DI
- 00810113680880
- Version / Model
- Kangaroo Shoulder Sling
- Catalog Number
- KSS001
- Company Name
- MANAMED INC
- Labeler DUNS
- 084042331
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-06-20
- Public Version
- 1
- Public Version Date
- 2022-06-28
- Public Version Status
- New
- Public Device Record Key
- 62216d6d-7c16-4c2f-b2ce-d0dc866bd921
Device Description
The Kangaroo Sling is universal and can be applied to right or left side. The breathable material allows for comfort and optimal patient experience. Kangaroo Sling comes with patent pending abduction pillow. Universal sizing, can be applied to left or right side of the patient. Abduction pillow allows user to carry water, coffee, and a mobile phone.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| ILI | Sling, Arm | Physical Medicine | 890.3640 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12101 | Shoulder immobilizer/orthosis, reusable | A prefabricated (non-customized) non-rigid wearable device designed to support, align, and/or temporarily immobilize the shoulder joint to support the healing of an injury or surgical wound. It will typically consist of straps, buckles, fasteners, or be in the form of a sling. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810113680880 | GS1 |
Customer Contacts
- Phone
- 888-508-0712
- [email protected]