FDA UDI
In Commercial Distribution
🇺🇸 United States
Design Options®
DI: 04046955672271
·
Model: 570330
·
B. BRAUN MEDICAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- Design Options®
- Primary DI
- 04046955672271
- Version / Model
- 570330
- Catalog Number
- 570330
- Company Name
- B. BRAUN MEDICAL INC.
- Labeler DUNS
- 002397347
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2021-02-22
- Public Version
- 1
- Public Version Date
- 2021-03-02
- Public Version Status
- New
- Public Device Record Key
- cd9c2f33-77e1-4387-b2a9-6f458592e7f5
Device Description
BPSK MEMORIAL HOSPITAL - NERVE BLOCK
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
- 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 |
|---|---|---|---|---|
| 64346 | Peripheral anaesthesia single-administration set, medicated | A collection of devices intended for the single-administration of an anaesthetic agent to function as a peripheral nerve-block. It includes a pharmaceutical anaesthetic agent with an anaesthesia needle and a syringe often with additional devices utilized for the procedure (e.g., dressings); as a single-administration set it does not include a catheter. 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 | 04046955672264 | GS1 | ||||
| Primary | 04046955672271 | GS1 |
Customer Contacts
- Phone
- +1(800)227-2862
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 1 – 40 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 20 – 25 Degrees Celsius