FDA UDI
In Commercial Distribution
🇺🇸 United States
Epidural Anesthesia Kit
DI: 00628725050041
·
Model: CPT10AT
·
CHS USA Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Epidural Anesthesia Kit
- Primary DI
- 00628725050041
- Version / Model
- CPT10AT
- Catalog Number
- CPT10AT
- Company Name
- CHS USA Inc.
- Labeler DUNS
- 118995594
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-11-24
- Public Version
- 1
- Public Version Date
- 2025-12-02
- Public Version Status
- New
- Public Device Record Key
- 7bac987c-2643-47a7-b954-3abe3f0394c0
Device Description
Needle Stick Pad, Syringe, 3cc and 5 cc LL, 1 - LIDOCAINEHCL - 1_5ML Lidocaine, 1%, 5ml Glass Ampule, neddle, L.O.R. Syringe (7ml, Luer Lock), Drape, Non-Woven, 24x24, 4" round, adhesive fen, Towel, Sponge Stick, PVP Solution 3/4oz, Gauze Sponge, Wrap
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- 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
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OGE | Epidural Anesthesia Kit | Anesthesiology | 868.5120 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61911 | Epidural anaesthesia set, medicated | A collection of devices intended for the administration of an analgesic or anaesthetic agent to the epidural space for the management of pain. It includes the pharmaceutical anaesthetic agent and a needle, with additional devices utilized for the procedure (e.g., syringe, dressings), and may include a catheter (i.e., may be intended for single- or continuous-administration). It is not intended for intrathetcal 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 | 50628725050046 | GS1 | 30 | In Commercial Distribution | ||
| Primary | 00628725050041 | GS1 |