Identity
- Trade Name
- True-Comfort Safety Pen Needles 5MM 31G FDA UDI
- Generic Name
- Subcutaneous infusion/injection port needle FDA UDI
- Device Name
- Safety Pen Needles 5MM 31G FDA UDI
- Model / Reference
- 2 FDA UDI
- Description
- Safety Pen Needles 5MM 31G FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850058864013 FDA UDI
- 510(k) Number
- K192677 FDA UDI
- FDA Product Code
- FMI FDA UDI
- GMDN Term
- Subcutaneous infusion/injection port needle FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 31 Gauge FDA UDILength — 5 Millimeter FDA UDI
Category: Subcutaneous infusion/injection port needle
True-Comfort Safety Pen Needles 5MM 31G by Home Aide Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Subcutaneous infusion/injection port needle.
- POLYPERF SAFE — PEROUSE MEDICAL · Class II
- PPS PI — PEROUSE MEDICAL · Class II
- PPS PI — PEROUSE MEDICAL · Class II
- POLYPERF SAFE — PEROUSE MEDICAL · Class II
- ProFusion — COOK INCORPORATED · Class I
- HIgH-Flo™ Needle Set — REPRO MED SYSTEMS, INC. · Class II
- PPS PI — PEROUSE MEDICAL · Class II
- HIgH-Flo™ Needle Set — REPRO MED SYSTEMS, INC. · Class II
Cleared under the same submission
K192677 also covers:
- BH Supplies — ANREL DISTRIBUTION LLC
- BH Supplies — ANREL DISTRIBUTION LLC
- BH Supplies — ANREL DISTRIBUTION LLC
- BH Supplies — ANREL DISTRIBUTION LLC
- BH Supplies — ANREL DISTRIBUTION LLC
- Pen Needle — GERI-GENTLE CORPORATION
- True Comfort Safety Pen Needles 4MM 32G — HOME AIDE DIAGNOSTICS, INC.
- True Comfort Safety Pen Needles 5MM 31G — HOME AIDE DIAGNOSTICS, INC.
- True Comfort Safety Pen Needles 6MM 31G — HOME AIDE DIAGNOSTICS, INC.
- True-Comfort Safety Pen Needles 4MM 32G — HOME AIDE DIAGNOSTICS, INC.
- True-Comfort Safety Pen Needles 6MM 31G — HOME AIDE DIAGNOSTICS, INC.
- ONE-CARE — MediVena, LLC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Home Aide Diagnostics, Inc.
Sources (1)
- FDA UDI 6ba1c828-68a5-4f62-8ae5-bd4fb4b63942 37 fields · synced Jun 1, 2026