FDA UDI
In Commercial Distribution
🇺🇸 United States
SAPS LifeStyle Comfort Surgical Stocking (20-30) X-LARGE
DI: 00891237001928
·
Model: 2030XL
·
HOME AIDE DIAGNOSTICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- SAPS LifeStyle Comfort Surgical Stocking (20-30) X-LARGE
- Primary DI
- 00891237001928
- Version / Model
- 2030XL
- Company Name
- HOME AIDE DIAGNOSTICS, INC.
- Labeler DUNS
- 783518983
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-14
- Public Version
- 1
- Public Version Date
- 2020-08-24
- Public Version Status
- New
- Public Device Record Key
- fcabef19-e5b1-403e-b772-9a3c5e32b262
Device Description
SAPS LifeStyle Comfort Surgical Stocking (20-30mmHg) Size: X-LARGE
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 |
|---|---|---|---|---|
| ITW | Joint, Ankle, External Brace | Physical Medicine | 890.3475 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42811 | Compression/pressure sock/stocking, reusable | A garment in the form of a sock or stocking intended to fit tightly over the leg and foot to apply compression/pressure (i.e., graduated or even-force), typically for the treatment/prevention of a disorder(s) of circulation [e.g., venous insufficiency, deep vein thrombosis (DVT)]. It is not a strip/roll binder or tubular support bandage, and is not designed to cover the pelvis. It is typically made of elastic material (e.g., circular knit nylon/Spandex yarns) and may be referred to as a flight sock; it does not include antimicrobial features. It is intended for use in the home or a clinical setting. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10891237001925 | GS1 | Carton | 50 | In Commercial Distribution | |
| Primary | 00891237001928 | GS1 |
Customer Contacts
- Phone
- 1-800-915-0116
- [email protected]