FDA UDI
Not in Commercial Distribution
🇺🇸 United States
BD PrepMate™ Installation Kit
DI: 00382904912888
·
Model: 491288
·
BECTON, DICKINSON AND COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BD PrepMate™ Installation Kit
- Primary DI
- 00382904912888
- Version / Model
- 491288
- Catalog Number
- 491288
- Company Name
- BECTON, DICKINSON AND COMPANY
- Labeler DUNS
- 122561087
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-09-08
- Public Version
- 6
- Public Version Date
- 2023-01-31
- Public Version Status
- Update
- Public Device Record Key
- 5c9b51e1-6a2b-432f-a07f-5e00d7fa5ba0
- Distribution End Date
- 2023-01-31
Device Description
BD PrepMate™ Installation Kit
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
- 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 |
|---|---|---|---|---|
| MKQ | Processor, Cervical Cytology Slide, Automated | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65667 | Endocervical specimen cytological examination kit IVD | A collection of noninvasive in vitro diagnostic devices intended to be used in the clinical laboratory for the preparation, processing, and microscopic examination of an endocervical cytological specimen previously collected from a patient, typically as part of a woman's regular pelvic examination and cervical cancer screening. It may be referred to as Papanicolaou (Pap) smear test and typically consists of specimen suspension homogenization reagents and preservatives, cytological centrifuge funnels, fixative/stain solutions, and microscopy slides. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00382904912888 | GS1 |
Customer Contacts
- Phone
- +1(800)638-8663
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P970018 | 028 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius