FDA UDI
In Commercial Distribution
🇺🇸 United States
BD Integra
DI: 00382903052752
·
Model: 305275
·
BECTON, DICKINSON AND COMPANY
Product Codes
1
GMDN Terms
2
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- BD Integra
- Primary DI
- 00382903052752
- Version / Model
- 305275
- Catalog Number
- 305275
- Company Name
- BECTON, DICKINSON AND COMPANY
- Labeler DUNS
- 001292192
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-16
- Public Version
- 5
- Public Version Date
- 2025-08-06
- Public Version Status
- Update
- Public Device Record Key
- bb1f5978-0b31-46bd-9ac1-881e68a6a08f
Device Description
NEEDLE INTEGRA 18X1-1/2 BLUNT FILL
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
- Yes
- 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 |
|---|---|---|---|---|
| MEG | SYRINGE, ANTISTICK | General Hospital | 880.5860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16627 | Medication transfer needle, non-filtering/non-vented | A slender, rigid, sharp or blunt metal tube intended to be attached to a syringe and typically used in the pharmacy to aspirate and transfer fluid medication from a vial/ampule to another container for medication preparation or other purposes. It consists of a short needle sufficient to penetrate the vial stopper and extract all the medication. It is typically of 20 gauge to provide a high-flow rate with minimum coring. It does not include a filter or a back-pressure venting feature. This is a single-use device. | No | Active |
| 64357 | Medication transfer straw | A slender flexible tube with a blunt distal end intended to be attached to a syringe to aspirate pharmaceutical fluids from an open vial or ampule during the preparation of medications performed by healthcare professionals (e.g., pharmacists, physicians, nurses); it is not intended to puncture the seal of a vial/container. It is typically made of plastic and may include an integral filter intended to retain micro-particles to reduce the risk of particle contamination of the patient medication. It is not intended for skin injections or tissue manipulation and is not intended for enteral use. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00382903052752 | GS1 | ||||
| Package | 30382903052753 | GS1 | Pack or Inner Pack | 100 | In Commercial Distribution | |
| Package | 50382903052757 | GS1 | Case | 10 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K011103 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 1.5 | Inch |