FDA UDI
In Commercial Distribution
🇺🇸 United States
Tamper Evident Cap with ENFit
DI: B212572201001
·
Model: 57-220-100
·
INTERNATIONAL MEDICAL INDUSTRIES INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
Basic Information
- Brand Name
- Tamper Evident Cap with ENFit
- Primary DI
- B212572201001
- Version / Model
- 57-220-100
- Catalog Number
- 57-220-100
- Company Name
- INTERNATIONAL MEDICAL INDUSTRIES INC.
- Labeler DUNS
- 053469565
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2023-07-12
- Public Version
- 1
- Public Version Date
- 2023-07-20
- Public Version Status
- New
- Public Device Record Key
- b35479a8-0ec6-4754-bda4-e7144f3307bc
Device Description
Tamper Evident Cap for Use With ENFit® Syringes (ETEC)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|---|---|
| Package | B21257220100 | HIBCC | Bag | 100 | In Commercial Distribution | |
| Primary | B212572201001 | HIBCC | ||||
| Unit of Use | B212572201000 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K170672 | 000 |