FDA UDI
In Commercial Distribution
🇺🇸 United States
Epimed International, Inc.
DI: 00818788021717
·
Model: 161-2114
·
EPIMED INTERNATIONAL, INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Epimed International, Inc.
- Primary DI
- 00818788021717
- Version / Model
- 161-2114
- Catalog Number
- 161-2114
- Company Name
- EPIMED INTERNATIONAL, INC
- Labeler DUNS
- 799751953
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-16
- Public Version
- 1
- Public Version Date
- 2022-12-26
- Public Version Status
- New
- Public Device Record Key
- 49dda577-fd9f-4367-9e69-17f4e41a6bab
Device Description
Versa XLC 21g x 12"
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
- 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
- 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 | 10818788021714 | GS1 | Case | 10 | In Commercial Distribution | |
| Primary | 00818788021717 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K023140 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 2.4Ch | ||
| Length | 12 | Inch | |
| Device Size Text, specify | 12in | ||
| Catheter Gauge | 2.4 | French |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 50 – 90 Degrees Fahrenheit