FDA UDI
In Commercial Distribution
🇺🇸 United States
BD Regional Anesthesia Support Tray
DI: 00382904008697
·
Model: 400869
·
BECTON, DICKINSON AND COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- BD Regional Anesthesia Support Tray
- Primary DI
- 00382904008697
- Version / Model
- 400869
- Catalog Number
- 400869
- Company Name
- BECTON, DICKINSON AND COMPANY
- Labeler DUNS
- 001292192
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-02
- Public Version
- 1
- Public Version Date
- 2023-09-11
- Public Version Status
- New
- Public Device Record Key
- 149c4383-882b-4f62-bd6c-72eb5326b408
Device Description
5ML GLASPAK 20G SPINAL INTRODUCER
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
- 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 |
|---|---|---|---|---|
| CAZ | Anesthesia conduction kit | Anesthesiology | 868.5140 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66346 | Local/regional anaesthesia support kit | A collection of noninvasive devices intended to support a local and/or regional anaesthesia procedure (e.g., spinal/epidural anaesthesia, peripheral nerve block). It includes supportive devices such as drapes, bowls, towels, and dressing forceps; neither a needle, anaesthesia catheter, nor medication is included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50382904008692 | GS1 | Case | 10 | In Commercial Distribution | |
| Primary | 00382904008697 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 20 – 25 Degrees Celsius