FDA UDI
In Commercial Distribution
🇺🇸 United States
ARROW
DI: 10801902208085
·
Model: IPN924013
·
TELEFLEX INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- ARROW
- Primary DI
- 10801902208085
- Version / Model
- IPN924013
- Catalog Number
- FB-19609-KU
- Company Name
- TELEFLEX INCORPORATED
- Labeler DUNS
- 002348191
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-14
- Public Version
- 2
- Public Version Date
- 2023-02-09
- Public Version Status
- Update
- Public Device Record Key
- c2a99e5e-b7be-4239-8bce-fc672fce7207
Device Description
FlexBlock(R) Continuous Peripheral Nerve Block Kit
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- Yes
- 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 |
|---|---|---|---|---|
| CAZ | Anesthesia conduction kit | Anesthesiology | 868.5140 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46383 | Peripheral anaesthesia catheter set, non-medicated | A collection of devices intended for the continuous-administration of an anaesthetic agent (not included) to function as a peripheral nerve-block. It includes an anaesthesia needle and an anaesthesia catheter usually with additional devices utilized for the procedure (e.g., connectors, catheter holder). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20801902208082 | GS1 | Case | 5 | Not in Commercial Distribution | 2023-02-08 |
| Primary | 10801902208085 | GS1 |
Customer Contacts
- Phone
- +1(919)544-8000
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 20 – 25 Degrees Celsius