FDA UDI
In Commercial Distribution
🇺🇸 United States
SAFE-T-FILL®
DI: 10643351000137
·
Model: 07 7340
·
Ram Scientific, Inc
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
50
Basic Information
- Brand Name
- SAFE-T-FILL®
- Primary DI
- 10643351000137
- Version / Model
- 07 7340
- Catalog Number
- 07 7340
- Company Name
- Ram Scientific, Inc
- Labeler DUNS
- 602759672
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2016-09-15
- Public Version
- 5
- Public Version Date
- 2022-12-22
- Public Version Status
- Update
- Public Device Record Key
- 9b2014d8-f3f4-419c-a118-95eb50cd0d1f
Device Description
SAFE-T-FILL® Micro Capillary Blood Collection, 200 µL; Prepared with Sodium Fluoride; Gray
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JKA | Tubes, vials, systems, serum separators, blood collection | Clinical Chemistry | 862.1675 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58153 | Capillary blood transfer tube IVD, sodium fluoride | A non-sterile glass or plastic capillary blood transfer tube coated internally with the antiglycolytic agent sodium fluoride, and intended to be attached to a non-evacuated blood collection tube to assist with the transfer of blood drops from the blood collection site into the collection tube using a capillary action. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50643351000135 | GS1 | CARTON | 80 | In Commercial Distribution | |
| Primary | 10643351000137 | GS1 | ||||
| Package | 30643351000131 | GS1 | CASE | 10 | In Commercial Distribution | |
| Unit of Use | 00643351000130 | GS1 |
Customer Contacts
- Phone
- +1(914)969-7900
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K983517 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 200 | Microliter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry.