FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Design Options®
DI: 04046964950551
·
Model: 570288
·
B. BRAUN MEDICAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- Design Options®
- Primary DI
- 04046964950551
- Version / Model
- 570288
- Catalog Number
- 570288
- Company Name
- B. BRAUN MEDICAL INC.
- Labeler DUNS
- 002397347
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2017-04-03
- Public Version
- 5
- Public Version Date
- 2021-12-27
- Public Version Status
- Update
- Public Device Record Key
- 437d9c97-bcb5-4f7c-8c1d-77d83f5c69b6
- Distribution End Date
- 2021-12-21
Device Description
PNB/Support Tray
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 Unsafe
- 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 |
|---|---|---|---|---|
| OGJ | Nerve block tray | Anesthesiology | 868.5140 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64347 | Peripheral anaesthesia catheter set, medicated | A collection of devices intended for the continuous-administration of an anaesthetic agent to function as a peripheral nerve-block. It includes a pharmaceutical anaesthetic agent, an anaesthesia catheter, and an anaesthesia needle usually with additional devices utilized for the procedure (e.g., connectors, catheter holder). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04046964950551 | GS1 | ||||
| Unit of Use | 04046964950544 | GS1 |
Customer Contacts
- Phone
- +1(800)227-2862
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Gauge (cannula) : 18 | ||
| Device Size Text, specify | Gauge (Catheter) : 20 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 20 – 25 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 1 – 40 Degrees Celsius