FDA UDI
In Commercial Distribution
🇺🇸 United States
Barkey plasmatherm C&G
DI: 04059201001817
·
Model: US-C&G
·
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 plasmatherm C&G
- Primary DI
- 04059201001817
- Version / Model
- US-C&G
- Catalog Number
- 00003475
- Company Name
- Barkey GmbH & Co. KG
- Labeler DUNS
- 312555782
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-11-12
- Public Version
- 1
- Public Version Date
- 2021-11-22
- Public Version Status
- New
- Public Device Record Key
- deb007c3-3cba-4a32-90f4-cf83b922293d
Device Description
Thawing and warming device for frozen plasma (FFP, PF24 ,AHF), Whole Blood, RBC and IV solution
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 |
|---|---|---|---|---|
| KZL | Device, Warming. Blood And Plasma | Hematology | 864.9205 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43434 | Cryopreserved blood/tissue thawing unit | An electrically-powered device intended to be used to thaw, in a controlled manner, frozen units of whole blood, blood components (e.g., blood cells, plasma), and/or other biological tissues contained in storage cryobags. The device is typically programmable and can use a number of heating methods to achieve thawing (e.g., dry heat, microwave oven, water bath); it may provide agitation and be able to detect when thawing has been completed. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04059201001817 | GS1 |
Customer Contacts
- Phone
- +18662275393
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK100063 | 0 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 70 Degrees Celsius