FDA UDI
In Commercial Distribution
🇺🇸 United States
Oral Tamper Evident Cap
DI: B2125770100RFID1
·
Model: 57-70-100 RFID
·
INTERNATIONAL MEDICAL INDUSTRIES INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
Basic Information
- Brand Name
- Oral Tamper Evident Cap
- Primary DI
- B2125770100RFID1
- Version / Model
- 57-70-100 RFID
- Catalog Number
- 57-70-100 RFID
- 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
- cb9d7ec5-60e3-4f75-b416-5c48c166c2e1
Device Description
RFID OTEC – 100 units/bag, 1 bag/carton
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| KYX | Dispenser, Liquid Medication | General Hospital | 880.6430 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65823 | Non-ISO80369-3-standardized oral syringe | A manual device consisting of a calibrated hollow barrel (cylinder) and a moveable plunger intended for the administration of oral medication. The tip is not formatted according to the standard for small-bore connectors for enteral applications (ISO 80369-3) [I.e., not ENFit], however the device may be colour-coded to distinguish it from syringes designed to mate with infusion/injection devices. It may include appropriate accessories (e.g., cap, bottle adaptor). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | B2125770100RFID2 | HIBCC | Box | 10 | In Commercial Distribution | |
| Primary | B2125770100RFID1 | HIBCC | ||||
| Unit of Use | B2125770100RFID0 | HIBCC |