FDA UDI
In Commercial Distribution
🇺🇸 United States
GUARDIVA
DI: 10801741085816
·
Model: FP-23-AD008
·
Bard Access Systems, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- GUARDIVA
- Primary DI
- 10801741085816
- Version / Model
- FP-23-AD008
- Catalog Number
- FP-23-AD008
- Company Name
- Bard Access Systems, Inc.
- Labeler DUNS
- 044611812
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2023-11-09
- Public Version
- 6
- Public Version Date
- 2025-11-20
- Public Version Status
- Update
- Public Device Record Key
- 00713860-c2a8-4b94-b5b2-1c6f7a6ac9e8
Device Description
GUARDIVA 1IN/ 4MM STERILE
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
- No
- 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 |
|---|---|---|---|---|
| FRO | Dressing, wound, drug | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65042 | Percutaneous catheter infection protector, professional | A dressing-like device intended to be used by a healthcare professional to cover and protect a percutaneous access cannula/catheter site (typically intravenous) to manage and help prevent complications (e.g., leakage, bleeding, infection). It is available in a variety of designs which may include a foam pad intended to absorb exudates/blood and a transparent shield that allows observation, sometimes with holes for ventilation. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10801741085816 | GS1 | ||||
| Unit of Use | 00801741085819 | GS1 | ||||
| Package | 20801741085813 | GS1 | Case | 10 | In Commercial Distribution |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Lumen/Inner Diameter | 4 | Millimeter | |
| Outer Diameter | 25 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 20 – 25 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry