FDA UDI
In Commercial Distribution
🇺🇸 United States
Matching Limb Protection Sleeves - Easi-Fit BFR
DI: M995979503001
·
Model: 9-7950-300
·
Delfi Medical Innovations Inc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
12
Basic Information
- Brand Name
- Matching Limb Protection Sleeves - Easi-Fit BFR
- Primary DI
- M995979503001
- Version / Model
- 9-7950-300
- Company Name
- Delfi Medical Innovations Inc
- Labeler DUNS
- 251078945
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 12
- Record Status
- Published
- Publish Date
- 2022-12-07
- Public Version
- 2
- Public Version Date
- 2024-02-05
- Public Version Status
- Update
- Public Device Record Key
- 492b0b99-c1a8-4bbb-9b7f-e0adda7aca3a
Device Description
Delfi Matching Limb Protection Sleeves (MLPS) help protect the patient’s limb from possible wrinkling, pinching and shearing of skin and soft tissues of the limb. Each Delfi Matching Limb Protection Sleeve is intended for use with a specific Delfi tourniquet cuff. This is a multi-pack set (4 of each 18"/24"/34").
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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 |
|---|---|---|---|---|
| FQL | Stocking, Medical Support (For General Medical Purposes) | General Hospital | 880.5780 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35374 | Stockinette | A knitted, seamless, expandable tubing, typically made of cotton, that is open at both ends and intended to be used to hold bandages in place; to place uniform pressure on a leg, finger, arm, or other part of an extremity; to pad the area under a cast, splint or orthosis; or to cover a stump when a prosthesis is worn. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M995979503001 | HIBCC | ||||
| Unit of Use | M995979503000 | HIBCC |
Customer Contacts
- Phone
- +16047420600
- [email protected]