FDA UDI
In Commercial Distribution
🇺🇸 United States
ARROW
DI: 10801902129335
·
Model: IPN037627
·
TELEFLEX INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- ARROW
- Primary DI
- 10801902129335
- Version / Model
- IPN037627
- Catalog Number
- JRT-43563-HPHNM
- Company Name
- TELEFLEX INCORPORATED
- Labeler DUNS
- 002348191
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-11-11
- Public Version
- 8
- Public Version Date
- 2022-10-24
- Public Version Status
- Update
- Public Device Record Key
- 03bb2d80-6b82-403b-9ffc-1b4a2c8468b8
Device Description
Arrowg+ard Blue Advance(TM) JACC
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- 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 |
|---|---|---|---|---|
| LJS | Catheter,intravascular,therapeutic,long-term greater than 30 days | General Hospital | 880.5970 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10729 | Centrally-inserted central venous catheter | A flexible tube intended to be introduced into a neck or thoracic vein and often advanced into the superior vena cava for various infusion/aspiration procedures (i.e., non-dedicated) including the intravenous administration of nutrients, fluids, chemotherapeutic agents or other drugs, and blood sampling or delivery; it may also be used to monitor venous pressure. The proximal end of this central venous catheter (CVC) is typically fixed to the patient for long-term use. It may include supportive devices associated with introduction (e.g., guidewire, introducer); it is not primarily intended for extracorporeal blood therapies such as haemodialysis. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20801902129332 | GS1 | Case | 5 | Not in Commercial Distribution | 2020-02-03 |
| Primary | 10801902129335 | GS1 |
Customer Contacts
- Phone
- +1(919)544-8000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K161765 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 6 | French |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Avoid excessive heat above 30°C (86°F).
- Type
- Storage Environment Temperature
- Temperature Range
- High: 25 Degrees Celsius