FDA UDI
In Commercial Distribution
🇺🇸 United States
Female NRFit Tip Cap
DI: B212576031
·
Model: 57-603
·
INTERNATIONAL MEDICAL INDUSTRIES INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
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Basic Information
- Brand Name
- Female NRFit Tip Cap
- Primary DI
- B212576031
- Version / Model
- 57-603
- Catalog Number
- 57-603
- Company Name
- INTERNATIONAL MEDICAL INDUSTRIES INC.
- Labeler DUNS
- 053469565
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2026-01-23
- Public Version
- 1
- Public Version Date
- 2026-02-02
- Public Version Status
- New
- Public Device Record Key
- cccd98eb-ac8f-422e-b771-14535ee782b4
Device Description
Female NRFit Tip Cap for male Neuraxial devices
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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QEH | Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact | General Hospital | 880.5860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65011 | NRFit-formatted protective cap | A small, noninvasive, closed-ended, NRFit-formatted (ISO 80369-6) attachment intended to be attached to a neuraxial device (e.g., epidural catheter, neuraxial filter or syringe) with an NRFit 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 | B212576032 | HIBCC | Box | 10 | In Commercial Distribution | |
| Primary | B212576031 | HIBCC | ||||
| Unit of Use | B212576030 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K201031 | 000 |