FDA UDI
In Commercial Distribution
🇺🇸 United States
ARROW
DI: 00801902056986
·
Model: IPN040122
·
TELEFLEX INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- ARROW
- Primary DI
- 00801902056986
- Version / Model
- IPN040122
- Catalog Number
- ASK-05560-WH
- Company Name
- TELEFLEX INCORPORATED
- Labeler DUNS
- 002348191
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-16
- Public Version
- 5
- Public Version Date
- 2021-02-15
- Public Version Status
- Update
- Public Device Record Key
- 5e77eae6-fac2-4751-8712-52ee4bf2747d
Device Description
FlexTip Plus(R) Combined Spinal Epidural Catheterization Kit
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
- MR Conditional
- 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 |
|---|---|---|---|---|
| BSO | CATHETER, CONDUCTION, ANESTHETIC | Anesthesiology | 868.5120 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46308 | Epidural/intrathecal anaesthesia set, non-medicated | A dual-purpose collection of devices intended for the administration of an analgesic or anaesthetic agent (not included) to the intrathecal space and to the epidural space for the management of pain. It includes both a spinal needle and an epidural needle with additional devices utilized for the procedure (e.g., dressings, syringe) and may include an epidural catheter for continuous-administration. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30801902056987 | GS1 | Case | 10 | In Commercial Distribution | |
| Primary | 00801902056986 | GS1 |
Customer Contacts
- Phone
- +1(919)544-8000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K140110 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 90 | Centimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 20 – 25 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store betweem 20-25C (68-77F). Avoid excessive heat above 40C (104F)