FDA UDI
In Commercial Distribution
🇺🇸 United States
EpiLong Cath
DI: 04048223073063
·
Model: 021151-37C
·
Pajunk GmbH Medizintechnologie
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- EpiLong Cath
- Primary DI
- 04048223073063
- Version / Model
- 021151-37C
- Catalog Number
- 021151-37C
- 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
- 2
- Public Version Date
- 2025-12-01
- Public Version Status
- Update
- Public Device Record Key
- a3f053ec-b4b2-4330-a4f5-94eb5b062cf2
Device Description
EpiLong Cath 20G x 90cm with closed tip, radiopaque line,
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 |
|---|---|---|---|---|
| CAZ | Anesthesia conduction kit | Anesthesiology | 868.5140 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64374 | Epidural anaesthesia stand-alone catheter | A flexible tube, supplied in isolation of other devices, intended to be percutaneously introduced into the epidural space for the delivery of an anaesthetic/analgesic agent; it is not coated with an antimicrobial agent. It is intended to be introduced using an epidural needle, however neither the needle nor other procedural assistive devices are included (i.e., the catheter is sold alone and this is not an epidural set). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 04048223052488 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 04048223073063 | GS1 |
Customer Contacts
- Phone
- +1 770-493-6832
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K060311 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 20.0 | Gauge | |
| Length | 90.0 | Centimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 20 – 65 Percent (%) Relative Humidity