FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Epimed
DI: 00818788020529
·
Model: 181-2540
·
EPIMED INTERNATIONAL, INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Epimed
- Primary DI
- 00818788020529
- Version / Model
- 181-2540
- Catalog Number
- 181-2540
- Company Name
- EPIMED INTERNATIONAL, INC
- Labeler DUNS
- 799751953
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-10-24
- Public Version
- 8
- Public Version Date
- 2023-08-21
- Public Version Status
- Update
- Public Device Record Key
- 4b958aaa-6add-4a34-926e-2a91b82cf7ee
- Distribution End Date
- 2023-08-18
Device Description
Tun-L-XL™ 19g x 33.25" w / R.K.™ 16g TW x 3.5" with Plastic L.O.R.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- Yes
- 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
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BSO | CATHETER, CONDUCTION, ANESTHETIC | Anesthesiology | 868.5120 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34842 | Epidural anaesthesia set, non-medicated | A collection of devices intended for the administration of an analgesic or anaesthetic agent (not included) to the epidural space for the management of pain. It includes a needle and/or a catheter with additional procedural devices (e.g., syringe, dressings, guidewire, introducer), and may be intended for single- or continuous-administration. It is not intended for intrathecal anaesthesia This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10818788020526 | GS1 | Case | 10 | Not in Commercial Distribution | 2023-08-18 |
| Primary | 00818788020529 | GS1 |
Customer Contacts
- Phone
- +1(800)866-3342
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K954584 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 3.2 | French | |
| Device Size Text, specify | 33.25" | ||
| Length | 3.5 | Inch | |
| Length | 33.25 | Inch | |
| Needle Gauge | 16 | Gauge | |
| Device Size Text, specify | 16g TW | ||
| Device Size Text, specify | 19g | ||
| Device Size Text, specify | 3.5" |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 50 – 90 Degrees Fahrenheit