FDA UDI
In Commercial Distribution
🇺🇸 United States
Tamper Evident Additive Port Cap
DI: B21221031001
·
Model: 21-03-100
·
INTERNATIONAL MEDICAL INDUSTRIES INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
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Basic Information
- Brand Name
- Tamper Evident Additive Port Cap
- Primary DI
- B21221031001
- Version / Model
- 21-03-100
- Catalog Number
- 21-03-100
- Company Name
- INTERNATIONAL MEDICAL INDUSTRIES INC.
- Labeler DUNS
- 053469565
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2022-10-10
- Public Version
- 2
- Public Version Date
- 2026-01-15
- Public Version Status
- Update
- Public Device Record Key
- b3597b8f-8ffa-48f0-9a87-9ea2084a70df
Device Description
"For use on the medication port of ICU Medical LifeCare ® to provide both visual evidence that medication has been added and tamper evidence once the device is closed. Packaged in Non-Sterile Bags of 50, 2 bags per shipper 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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KPE | Container, I.V. | General Hospital | 880.5025 | 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 | B21221031002 | HIBCC | Box | 2 | In Commercial Distribution | |
| Primary | B21221031001 | HIBCC | ||||
| Unit of Use | B21221031000 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K190305 | 000 |