FDA UDI
In Commercial Distribution
🇺🇸 United States
BD BBL™ PYR Reagent Dropper
DI: 30382902611968
·
Model: 261196
·
BECTON, DICKINSON AND COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
Basic Information
- Brand Name
- BD BBL™ PYR Reagent Dropper
- Primary DI
- 30382902611968
- Version / Model
- 261196
- Catalog Number
- 261196
- Company Name
- BECTON, DICKINSON AND COMPANY
- Labeler DUNS
- 122561087
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2018-05-25
- Public Version
- 1
- Public Version Date
- 2018-06-25
- Public Version Status
- New
- Public Device Record Key
- 4ca5cf73-fb96-4275-abaf-2753f261948e
Device Description
BD BBL™ PYR Reagent Dropper
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
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JTO | DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION | Microbiology | 866.2660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35998 | Pyrrolidonyl arylamidase (PYR) microbial reagent IVD | A substance or reactant intended to be used in microbial testing for the detection of pyrrolidonyl arylamidase (PYR) production and/or activity, for the presumptive identification of beta-haemolytic Streptococcus (Lancefield) group A and Enterococcus species (Lancefield) group D bacteria, activity in a clinical specimen and/or culture isolate. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 30382902611968 | GS1 | ||||
| Unit of Use | 00382902611967 | GS1 |
Customer Contacts
- Phone
- +1(800)638-8663
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 0.5 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius