FDA UDI
In Commercial Distribution
🇺🇸 United States
Chemo Vent
DI: B21231501
·
Model: 31-50
·
INTERNATIONAL MEDICAL INDUSTRIES INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Chemo Vent
- Primary DI
- B21231501
- Version / Model
- 31-50
- Catalog Number
- 31-50
- Company Name
- INTERNATIONAL MEDICAL INDUSTRIES INC.
- Labeler DUNS
- 053469565
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-22
- Public Version
- 5
- Public Version Date
- 2026-01-26
- Public Version Status
- Update
- Public Device Record Key
- c7b9ba3a-05c1-4070-a683-a765b79acc7d
Device Description
Venting Needle Filtered (Red) with 0.2 micron hydrophobic filter, 20 gauge x 1.5" stainless steel non-coring needle, packaged sterile, individual blister packs, 100 units per box
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 |
|---|---|---|---|---|
| LHI | Set, I.V. Fluid Transfer | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63459 | Hydrophobic Luer filter | A device intended to be attached to equipment during a medical/surgical procedure and/or to a needle during drug preparation (i.e., vial venting) to prevent the transfer of microbes, particulates and aerosols while allowing passage of air/gas; its use is not dedicated to a specific type of medical equipment. It is a small plastic housing containing a hydrophobic filter with male and female Luer connections (Luer-lock or Luer-slip). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | B21231502 | HIBCC | Box | 100 | In Commercial Distribution | |
| Primary | B21231501 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K860434 | 000 |