FDA UDI
In Commercial Distribution
🇺🇸 United States
ALP®
DI: 00857910006000
·
Model: ALP® 1 CALF-R
·
Cavalier Alp, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- ALP®
- Primary DI
- 00857910006000
- Version / Model
- ALP® 1 CALF-R
- Catalog Number
- 500002
- Company Name
- Cavalier Alp, LLC
- Labeler DUNS
- 105514832
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-07-26
- Public Version
- 3
- Public Version Date
- 2024-06-10
- Public Version Status
- Update
- Public Device Record Key
- 07ee31ce-74f8-4174-8ce4-4f1d0a5bd1f2
Device Description
ALP 1 CALF-R - Garment (Calf, Adult)
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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 |
|---|---|---|---|---|
| 44769 | Single-chamber venous compression system garment, single-use | An 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 intermittent inflation of a single-chamber. 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 single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00857910006000 | GS1 | ||||
| Package | 00857910006505 | GS1 | Case 10 Pr | 20 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K955853 | 000 |