FDA UDI
In Commercial Distribution
🇺🇸 United States
E-Cath® II Plus Tsui® NRFit
DI: 04048223122143
·
Model: 311165-41E
·
Pajunk GmbH Medizintechnologie
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- E-Cath® II Plus Tsui® NRFit
- Primary DI
- 04048223122143
- Version / Model
- 311165-41E
- Catalog Number
- 311165-41E
- Company Name
- Pajunk GmbH Medizintechnologie
- Labeler DUNS
- 317654283
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-01-30
- Public Version
- 1
- Public Version Date
- 2025-02-07
- Public Version Status
- New
- Public Device Record Key
- 03de8f1b-bd69-4bab-aa22-1e5759f94a1b
Device Description
E-Cath® II Plus Tsui® NRFit SonoPlex® II Facet S NRFit 21G with indwelling catheter 18G x 80mm
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- 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
- 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 |
|---|---|---|---|---|
| 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 | 04048223122150 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 04048223122143 | GS1 |
Customer Contacts
- Phone
- +1 770-493-6832
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K152952 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 80.0 | Millimeter | |
| Needle Gauge | 18.0 | Gauge |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 20 – 65 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius