FDA UDI
Not in Commercial Distribution
🇺🇸 United States
ACHIEVE
DI: 10885403238055
·
Model: BA149
·
CAREFUSION 2200, INC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- ACHIEVE
- Primary DI
- 10885403238055
- Version / Model
- BA149
- Catalog Number
- BA149
- Company Name
- CAREFUSION 2200, INC
- Labeler DUNS
- 832696038
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-03-08
- Public Version
- 3
- Public Version Date
- 2023-10-04
- Public Version Status
- Update
- Public Device Record Key
- 902498ac-4a13-47c6-9b96-bc4417b27bd3
- Distribution End Date
- 2019-11-30
Device Description
Programmable Automatic Biopsy System 14G X 9CM
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
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KNW | INSTRUMENT, BIOPSY | Gastroenterology, Urology | 876.1075 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16835 | Soft-tissue biopsy procedure kit, non-medicated | A collection of sterile devices designed to perform a non-specific soft tissue biopsy. It includes the biopsy needle used for this procedure; it does not include a pharmaceutical. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50885403238053 | GS1 | Case | 5 | Not in Commercial Distribution | 2019-11-30 |
| Primary | 10885403238055 | GS1 | ||||
| Package | 20885403238052 | GS1 | Box | 12 | Not in Commercial Distribution | 2019-11-30 |
Customer Contacts
- Phone
- +1(800)323-9088
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 14 | Gauge | |
| Length | 9 | Centimeter |