Identity
- Trade Name
- Red Tunica FDA UDI
- Generic Name
- Insulin syringe/needle, basic FDA UDI
- Device Name
- Disposable Insulin Syringe With Needle For Single Use - 31G 0.3mL 8mm - 100 Pcs Box // 10 Bags of 10 Pcs FDA UDI
- Model / Reference
- RT-37313 FDA UDI
- Description
- Disposable Insulin Syringe With Needle For Single Use - 31G 0.3mL 8mm - 100 Pcs Box // 10 Bags of 10 Pcs FDA UDI
Identifiers
- Catalog Number
- RT-37313 FDA UDI
- Primary DI / UDI-DI
- 00850036464501 FDA UDI
- 510(k) Number
- K151949 FDA UDI
- FDA Product Code
- FMF FDA UDI
- GMDN Term
- Insulin syringe/needle, basic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5860 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
No
FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 31 Gauge FDA UDILength — 8 Millimeter FDA UDITotal Volume — 0.3 Milliliter FDA UDI
Category: Insulin syringe/needle, basic
Red Tunica by Rodimedi & Associates, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Insulin syringe/needle, basic.
- EasyTouch — MHC Medical Products · Class II
- EasyTouch — MHC Medical Products · Class II
- BH Supplies — ANREL DISTRIBUTION LLC · Class II
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- droplet insulin syringes — HTL STREFA S A · Class II
- Insulin Syringe — Dynarex Corp. · Class II
- LiteTouch — AMITY HOLDINGS, LLC · Class II
- Ultra-Care Insulin Syringe 30G 5/16" 0.5 CC 100 Ct — ARISE MEDICAL LLC · Class II
Cleared under the same submission
K151949 also covers:
- Monoject — Cardinal Health 200, LLC
- Monoject — Cardinal Health 200, LLC
- Monoject — Cardinal Health 200, LLC
- DOPE DOCTORS — Jiangsu Caina Medical Co., Ltd
- DOPE DOCTORS — Jiangsu Caina Medical Co., Ltd
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
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 |
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Manufacturer
- Manufacturer
- Rodimedi & Associates, Inc.
Sources (1)
- FDA UDI 4c070c16-acd2-4e71-93a8-4613b3a38c56 37 fields · synced Jun 1, 2026