FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Surgicutt Bleeding Time Blotting Paper
DI: 20711234311032
·
Model: SUP100I
·
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
Basic Information
- Brand Name
- Surgicutt Bleeding Time Blotting Paper
- Primary DI
- 20711234311032
- Version / Model
- SUP100I
- Catalog Number
- SUP100I
- Company Name
- ACCRIVA DIAGNOSTICS HOLDINGS, INC.
- Labeler DUNS
- 079299318
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2016-09-22
- Public Version
- 5
- Public Version Date
- 2023-05-12
- Public Version Status
- Update
- Public Device Record Key
- 687b9b41-966a-49d8-bd59-dc1df7132b03
- Distribution End Date
- 2022-11-22
Device Description
Surgicutt Bleeding Time Blotting Paper 100/box
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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| FRL | Fiber, Medical, Absorbent | General Hospital | 880.5300 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45522 | Blood collection paper | A non-sterile filter-paper card intended to be used as a medium for the collection and transport of blood specimen spots to a laboratory for testing. It provides a uniform surface for the collection of blood spot specimens taken from the patient. Also known as an Ahlstrom 226 specimen collection paper or a Whatman body fluid collection paper, it may incorporate a tear-apart form for demographic information. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 20711234311032 | GS1 | ||||
| Unit of Use | 00711234311038 | GS1 |
Customer Contacts
- Phone
- 1-800-678-0710
- [email protected]