FDA UDI
In Commercial Distribution
🇺🇸 United States
Universal connector 1/4 x 1/4 Fr 24-36
DI: 08034139290959
·
Model: 10507
·
REDAX SPA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Universal connector 1/4 x 1/4 Fr 24-36
- Primary DI
- 08034139290959
- Version / Model
- 10507
- Catalog Number
- 10507
- Company Name
- REDAX SPA
- Labeler DUNS
- 338664915
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-05-11
- Public Version
- 1
- Public Version Date
- 2021-05-19
- Public Version Status
- New
- Public Device Record Key
- 9b06a0b3-0f37-43a7-8271-c9a9d22c95ec
Device Description
Fittinig device designed to facilitate the connection of the tubes/drainage catheters.
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
- No
- 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 |
|---|---|---|---|---|
| GCD | Connector, Catheter | General, Plastic Surgery | 878.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45389 | Closed-wound drain connector | A tubular, noninvasive device designed to connect compatible components of a closed-wound drainage kit (e.g., the drain tubing to the drain bag or reservoir); it is not intended to connect components of suction systems (e.g., not used in general surgery). It will typically be shaped as a straight bore connector or a Y-piece connector. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08034139290959 | GS1 |
Customer Contacts
- Phone
- +17868187337
- [email protected]
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 60 Degrees Celsius