FDA UDI
In Commercial Distribution
🇺🇸 United States
Tamper Evident Cap for use with ENFit Syringes
DI: B212572201
·
Model: 57-220
·
INTERNATIONAL MEDICAL INDUSTRIES INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
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Basic Information
- Brand Name
- Tamper Evident Cap for use with ENFit Syringes
- Primary DI
- B212572201
- Version / Model
- 57-220
- Catalog Number
- 57-220
- Company Name
- INTERNATIONAL MEDICAL INDUSTRIES INC.
- Labeler DUNS
- 053469565
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2017-10-26
- Public Version
- 5
- Public Version Date
- 2026-01-20
- Public Version Status
- Update
- Public Device Record Key
- 79c57b91-ca93-4130-a8ad-1a3cfb8c6bac
Device Description
Tamper Evident Cap for use with ENFit Syringes, Purple. Non-sterile. Bag of 100. Package of 1000. Provides positive closure and tamper evidence.
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 |
|---|---|---|---|---|
| PNR | Enteral Syringes With Enteral Specific Connectors | Gastroenterology, Urology | 876.5980 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65012 | ENFit-formatted protective cap | A small, noninvasive, closed-ended, ENFit-formatted (ISO 80369-3) attachment intended to be attached to an enteral device (e.g., enteral syringe, feeding tube, administration set) with an ENFit 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 |
|---|---|---|---|---|---|---|
| Primary | B212572201 | HIBCC | ||||
| Unit of Use | B212572200 | HIBCC | ||||
| Package | B212572202 | HIBCC | Box | 10 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K170672 | 000 |