FDA UDI
In Commercial Distribution
🇺🇸 United States
Female-Female Luer Lock
DI: B21257131
·
Model: 57-13
·
INTERNATIONAL MEDICAL INDUSTRIES INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Female-Female Luer Lock
- Primary DI
- B21257131
- Version / Model
- 57-13
- Catalog Number
- 57-13
- Company Name
- INTERNATIONAL MEDICAL INDUSTRIES INC.
- Labeler DUNS
- 053469565
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-22
- Public Version
- 4
- Public Version Date
- 2026-01-15
- Public Version Status
- Update
- Public Device Record Key
- ce543b8b-e839-472f-9fca-9442206b4b04
Device Description
Female - Female Luer Lock Connector, Sterile, Non-Pyrogenic, Individually Blister Packed, Box of 100
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
- Yes
- 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 |
|---|---|---|---|---|
| FPA | Set, Administration, Intravascular | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60538 | Luer/Luer linear connector, single-use | A small, non-powered, noninvasive tubular, two-way/linear connector with a Luer connection (either lock or slip) at both ends intended to connect two luminal devices (e.g., catheter, tubing, container) with each other. It may have a straight or elbow shape; it does not incorporate a filter, valve, clamp, tubing nor puncturing component. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B21257131 | HIBCC | ||||
| Package | B21257132 | HIBCC | Box | 100 | In Commercial Distribution |