FDA UDI
In Commercial Distribution
🇺🇸 United States
HOMECHOICE APD SET
DI: 07332414208479
·
Model: 5C4469C
·
Vantive US Healthcare LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- HOMECHOICE APD SET
- Primary DI
- 07332414208479
- Version / Model
- 5C4469C
- Catalog Number
- 5C4469C
- Company Name
- Vantive US Healthcare LLC
- Labeler DUNS
- 119181963
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-10-16
- Public Version
- 1
- Public Version Date
- 2025-10-24
- Public Version Status
- New
- Public Device Record Key
- f30555b3-a951-417b-9ab6-962cefb45fd8
Device Description
HOMECHOICE APD SET WITH CASSETTE AND 4 PRONG SPIKE
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FKX | System, peritoneal, automatic delivery | Gastroenterology, Urology | 876.5630 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35000 | Peritoneal dialysis system tubing set | A sterile set intended for the administration of peritoneal dialysis. It will typically consist of tubing, an optional reservoir bag, and appropriate connectors. It may include a peritoneal dialysis filter to trap and remove contaminating particles. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 57332414208474 | GS1 | CASE | 30 | In Commercial Distribution | |
| Primary | 07332414208479 | GS1 | ||||
| Previous | 00085412087375 | GS1 |
Customer Contacts
- Phone
- +1(888)736-2543
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K923065 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at room temperature.