FDA UDI
In Commercial Distribution
🇺🇸 United States
CER-JUVA-BD ASSEMBLY
DI: 00850023741929
·
Model: CER-JUVA-BD
·
RANFAC CORP.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- CER-JUVA-BD ASSEMBLY
- Primary DI
- 00850023741929
- Version / Model
- CER-JUVA-BD
- Company Name
- RANFAC CORP.
- Labeler DUNS
- 121622872
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-15
- Public Version
- 1
- Public Version Date
- 2024-05-23
- Public Version Status
- New
- Public Device Record Key
- 49d01ad0-ec09-4a3d-af8a-f0c0c466c3d6
Device Description
CER-JUVA-BD Assembly PN 69014-01M
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
- Yes
- 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 |
|---|---|---|---|---|
| KDD | Kit, Surgical Instrument, Disposable | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35209 | Non-fixed blood collection needle | A sharp bevel-edged, hollow tubular metal instrument intended to be used as part of a blood collection set for drawing blood from a patient; it does not include wings for fixation/placement (i.e., not a venous butterfly/scalp vein needle). It is intended to be connected to blood collection tubing and/or a blood collection Luer connector for transfer into a blood specimen receptacle. It may include a pre-attached blood collection tube spike and/or a safety cover; however, it does not include blood collection tubing or a tube holder (i.e., not a set). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850023741929 | GS1 |
Customer Contacts
- Phone
- 5085884400
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Avoid excessive heat. Protect from freezing. Protect from direct sunlight.