FDA UDI
In Commercial Distribution
🇺🇸 United States
Espocan®
DI: 04046955899531
·
Model: 333196
·
B. BRAUN MEDICAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
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Basic Information
- Brand Name
- Espocan®
- Primary DI
- 04046955899531
- Version / Model
- 333196
- Catalog Number
- 333196
- Company Name
- B. BRAUN MEDICAL INC.
- Labeler DUNS
- 002397347
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2024-10-03
- Public Version
- 1
- Public Version Date
- 2024-10-11
- Public Version Status
- New
- Public Device Record Key
- 2e1e8ba5-146d-426f-b4b9-2b78be96bce9
Device Description
ESPOCAN® 17 Ga. x 3-1/2 in. Tuohy, PENCAN® 25 Ga. x 5 in. Pencil-Point Spinal Needle, PERIFIX® FX 19 Ga. Springwound Closed Tip, 5 mL Glass Luer Slip LOR Tray (Kit)
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
- MR Conditional
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OFT | Spinal epidural anesthesia kit | Anesthesiology | 868.5120 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46308 | Epidural/intrathecal anaesthesia set, non-medicated | A dual-purpose collection of devices intended for the administration of an analgesic or anaesthetic agent (not included) to the intrathecal space and to the epidural space for the management of pain. It includes both a spinal needle and an epidural needle with additional devices utilized for the procedure (e.g., dressings, syringe) and may include an epidural catheter for continuous-administration. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 04046955899548 | GS1 | ||||
| Primary | 04046955899531 | GS1 |
Customer Contacts
- Phone
- +1(800)227-2862
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Gauge spinal needle : 25 | ||
| Device Size Text, specify | Gauge (Catheter) : 19 | ||
| Device Size Text, specify | Gauge epidural needle : 17 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 20 – 25 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 1 – 40 Degrees Celsius