FDA UDI
In Commercial Distribution
🇺🇸 United States
Barkey S-line
DI: 04059201002203
·
Model: 39 °C
·
Barkey GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Barkey S-line
- Primary DI
- 04059201002203
- Version / Model
- 39 °C
- Company Name
- Barkey GmbH & Co. KG
- Labeler DUNS
- 312555782
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-06-13
- Public Version
- 1
- Public Version Date
- 2022-06-21
- Public Version Status
- New
- Public Device Record Key
- 86ac296b-d49d-4899-8ff7-8e05cb40687a
Device Description
The device delivers warm blood, blood products, and liquids to adult and pediatric patients
Device Characteristics
- Single Use
- No
- 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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LGZ | Warmer, Thermal, Infusion Fluid | General Hospital | 880.5725 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47616 | Conduction blood/fluid warmer | An electrically-powered device designed for in-line heating of banked blood, blood products, intravenous (IV) solutions, and irrigation fluids, typically from about 4ºC to near body temperature (i.e., 35 to 37ºC) before infusion, through the conduction of heat. The device usually includes a surface heat exchanger (e.g., heated dry plate) for the conduction of heat to the infusion blood/fluid via a disposable set (e.g., tubing or pouch); it also includes temperature controls and/or alarms. It is typically mounted on an IV pole under the infusion bag; it does not infuse blood/fluid. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04059201002203 | GS1 |
Customer Contacts
- Phone
- +18662275393
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K213191 | 000 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 70 Degrees Celsius