FDA UDI
In Commercial Distribution
🇺🇸 United States
SAFECAN™
DI: 04046964309021
·
Model: 613105
·
B. BRAUN MEDICAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
Basic Information
- Brand Name
- SAFECAN™
- Primary DI
- 04046964309021
- Version / Model
- 613105
- Catalog Number
- 613105
- Company Name
- B. BRAUN MEDICAL INC.
- Labeler DUNS
- 002397347
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 6
- Public Version Date
- 2023-07-17
- Public Version Status
- Update
- Public Device Record Key
- 7b8e584c-6132-40cb-b184-688c2613206d
Device Description
STERILE PK SAFECAN 18G, 2.75 IN. B BEVEL
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
- No
- 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 |
|---|---|---|---|---|
| DYB | INTRODUCER, CATHETER | Cardiovascular | 870.1340 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34905 | Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous | A semi-rigid or rigid tube intended to be surgically inserted into the right atrium or large vein to serve as a channel for the extracorporeal transport of deoxygenated blood from a patient during cardiopulmonary bypass and/or extracorporeal membrane oxygenation. It is typically inserted using a compatible trocar blade which may be included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04046964309021 | GS1 | ||||
| Unit of Use | 04046964309007 | GS1 |
Customer Contacts
- Phone
- +1(800)227-2862
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Length of cannula (metric) : 7.000 CM | ||
| Device Size Text, specify | Gauge (cannula) : 18 | ||
| Device Size Text, specify | Length of cannula (inch) : 2 3/4" |