FDA UDI
In Commercial Distribution
🇺🇸 United States
TidalPort Vascular Access Port
DI: M991SP212211
·
Model: TidalPort
·
NORFOLK MEDICAL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TidalPort Vascular Access Port
- Primary DI
- M991SP212211
- Version / Model
- TidalPort
- Catalog Number
- SP21221
- Company Name
- NORFOLK MEDICAL
- Labeler DUNS
- 013861471
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-01
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- f27af256-0ec5-4fb4-8cb1-6c7b0733b601
Device Description
Low-Profile Titanium TidalPort Vascular Access Port with 5F preattached Polyurethane Catheter
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- Yes
- 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
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LJT | PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR | General Hospital | 880.5965 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35911 | Infusion/injection port, implantable | A sterile metallic and/or non-metallic device intended to be implanted subcutaneously in a patient for the short- or long-term delivery of fluids or medications to the vascular system or other anatomical region. The device consists of a housing with a self-sealing septum and a catheter connection mechanism. The device may be implanted in various anatomical locations. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M991SP212211 | HIBCC |
Customer Contacts
- Phone
- +1(847)674-7075 ext. 102
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 0.333 | Milliliter |