FDA UDI
In Commercial Distribution
🇺🇸 United States
Safe-T-Vue 6
DI: 10852282007157
·
Model: STV6
·
Temptime Corporation
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
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Basic Information
- Brand Name
- Safe-T-Vue 6
- Primary DI
- 10852282007157
- Version / Model
- STV6
- Catalog Number
- 7206-50
- Company Name
- Temptime Corporation
- Labeler DUNS
- 152578522
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2019-10-29
- Public Version
- 1
- Public Version Date
- 2019-11-06
- Public Version Status
- New
- Public Device Record Key
- d9e61c68-3a24-470a-8230-f760f47beabf
Device Description
A blood bag temperature monitor for use by health care providers to determine if blood or blood products have reached or exceeded the indication temperature.
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
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| KSS | Supplies, Blood-Bank | Hematology | 864.9050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60964 | Medical product temperature point indicator, thermochemical | A small device intended to be attached to a bag containing a temperature-sensitive medical product (e.g., blood, pharmaceutical) to indicate, by non-reversible chemical colour change, when a predetermined temperature is reached and exceeded, potentially making the product non-viable. It typically consists of a self-adhesive plastic container that holds a patch of heat-sensitive material which is activated when the container is attached to the product of interest. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10852282007157 | GS1 | ||||
| Unit of Use | 00852282007150 | GS1 | ||||
| Package | 20852282007154 | GS1 | Case of 200 | 4 | In Commercial Distribution |
Customer Contacts
- Phone
- 973-630-6000
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Refrigerate at the same temperature as the blood for a minimum of 24 hours prior to use.
- Type
- Storage Environment Temperature
- Temperature Range
- 1 – 25 Degrees Celsius