FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Kendall
DI: 10817357020165
·
Model: 9529
·
HYGIA HEALTH SERVICES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Kendall
- Primary DI
- 10817357020165
- Version / Model
- 9529
- Company Name
- HYGIA HEALTH SERVICES, INC.
- Labeler DUNS
- 177939027
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 4
- Public Version Date
- 2021-03-19
- Public Version Status
- Update
- Public Device Record Key
- 91af112c-4518-4bb8-b22a-e6e68b9e5e31
- Distribution End Date
- 2019-07-31
Device Description
Kendall SCD Express Knee Length, Medium
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| JOW | Sleeve, Limb, Compressible | Cardiovascular | 870.5800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61810 | Multi-chamber venous compression system garment, reprocessed | A non-sterile inflatable device in the form of a stocking, sleeve, or suit intended to be applied to the limbs externally to promote venous blood flow. As part of a compression system, the device applies pressure to the extremities through the sequential inflation of several chambers. The resulting increased venous blood flow may help to treat/prevent oedema, deep vein thrombosis (DVT) and pulmonary embolism (PE) in non-ambulatory patients or patients at risk. This is a previously used single-use device that has been processed for an additional single-use patient application. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30817357020169 | GS1 | Box | 5 | Not in Commercial Distribution | 2021-03-19 |
| Primary | 10817357020165 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K053575 | 000 |