FDA UDI
In Commercial Distribution
🇺🇸 United States
ASK-1 Aspiration Starter Kit
DI: 00857878007255
·
Model: 1
·
RANFAC CORP.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- ASK-1 Aspiration Starter Kit
- Primary DI
- 00857878007255
- Version / Model
- 1
- Catalog Number
- ASK-1
- Company Name
- RANFAC CORP.
- Labeler DUNS
- 121622872
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-03-07
- Public Version
- 5
- Public Version Date
- 2021-06-22
- Public Version Status
- Update
- Public Device Record Key
- 521f50a8-53cf-4dc8-9190-143bf962b14b
Device Description
ASK-1, Aspiration Starter Kit P/N 74312-01M
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| POZ | Biopsy Needle Kit | Gastroenterology, Urology | 876.1075 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62934 | Surgical dressing/drape kit, single-use | A collection of various types of patient drapes, dressings, covers and/or towels intended to be used to facilitate a surgical procedure. It does not include any pharmaceuticals, surgical instruments, surgical tubing, or mechanically functional devices and is not dedicated to catheterization support. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20857878007259 | GS1 | Case | 3 | Not in Commercial Distribution | 2019-03-20 |
| Package | 10857878007252 | GS1 | Inner Pack | 5 | In Commercial Distribution | |
| Primary | 00857878007255 | GS1 | ||||
| Package | 30857878007256 | GS1 | Case | 4 | In Commercial Distribution |
Customer Contacts
- Phone
- 5085884400
- [email protected]