FDA UDI
In Commercial Distribution
🇺🇸 United States
Arpovo Health
DI: 00860014354816
·
Model: 1
·
ARPOVO, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Arpovo Health
- Primary DI
- 00860014354816
- Version / Model
- 1
- Catalog Number
- GH-SK-01
- Company Name
- ARPOVO, LLC
- Labeler DUNS
- 038921991
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-20
- Public Version
- 1
- Public Version Date
- 2026-04-28
- Public Version Status
- New
- Public Device Record Key
- 43ff30a5-faea-4d44-8155-40b85d26bac2
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OJA | Intravenous Extension Tubing Set | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 67597 | General-purpose hypodermic injection kit | A collection of devices which includes a hypodermic needle(s) intended to be used by a healthcare practitioner for administration of fluids (e.g., medication) into a patient; it is not dedicated to a specific clinical specialty and is not intended for self-administration. In addition to the hypodermic needle, it includes a syringe (which may have a Luer-lock adaptor for use during intravenous (IV) administration via connection to an IV line) and additional supportive devices [e.g., adhesive strip/plaster, alcohol wipes, antiseptic agents, disposable gloves]. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860014354816 | GS1 |