FDA UDI
In Commercial Distribution
🇺🇸 United States
PICC Guard
DI: B38320517205181
·
Model: 1
·
PICCGUARD, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- PICC Guard
- Primary DI
- B38320517205181
- Version / Model
- 1
- Catalog Number
- 2051720518
- Company Name
- PICCGUARD, LLC
- Labeler DUNS
- 117382745
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-28
- Public Version
- 2
- Public Version Date
- 2024-11-25
- Public Version Status
- Update
- Public Device Record Key
- beef35ba-1cfa-4f2b-96c4-f204f6902afb
Device Description
Tamper-evident catheter access cover
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
- 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 |
|---|---|---|---|---|
| PZW | Catheter Access Cover, Tamper-Resistant | General Hospital | 880.5970 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64905 | Intravenous catheter injection port guard | A box-like device intended to attach to and encompass the proximal end/port of an in situ intravenous catheter to create a protective cover for the prevention of unauthorized intravenous access and/or tampering by the patient or other non-healthcare provider. It typically consists of a plastic box with a locking lid, which cannot be removed without being destroyed and providing tamper evidence. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B38320517205181 | HIBCC |
Customer Contacts
- Phone
- 9185192563
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K191195 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- – 100 Degrees Fahrenheit