FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Tamper Evident Cap
DI: B21257641
·
Model: 57-64
·
INTERNATIONAL MEDICAL INDUSTRIES INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
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Basic Information
- Brand Name
- Tamper Evident Cap
- Primary DI
- B21257641
- Version / Model
- 57-64
- Catalog Number
- 57-64
- Company Name
- INTERNATIONAL MEDICAL INDUSTRIES INC.
- Labeler DUNS
- 053469565
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 4
- Public Version Date
- 2026-01-15
- Public Version Status
- Update
- Public Device Record Key
- 775e1f4a-a158-44ec-a524-695dafd0c310
- Distribution End Date
- 2020-12-31
Device Description
Warm Grey Tamper Evident Luer Lock Caps for IV Syringes. Sterile, Tray of 10, box of 1000. Provides Evidence of Access and maintains sterility. Includes OEM cosmetic logo
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 |
|---|---|---|---|---|
| FMF | Syringe, Piston | General Hospital | 880.5860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63614 | Luer-formatted protective cap | A small, noninvasive, closed-ended Luer attachment intended to be attached to a luminal device (e.g., catheter, intravenous administration or pressure-monitoring tubing, syringe) with a Luer connection to close the device lumen, typically to prevent fluid path contamination and/or spillage; it is not intended to disinfect/maintain disinfection. It is typically made of synthetic polymers and may incorporate a strap; it does not incorporate a filter or valve. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | B21257642 | HIBCC | Box | 100 | Not in Commercial Distribution | 2020-12-31 |
| Primary | B21257641 | HIBCC | ||||
| Unit of Use | B21257640 | HIBCC |