Identity
- Trade Name
- Qitexio FDA UDI
- Generic Name
- General-purpose syringe, single-use FDA UDI
- Device Name
- 1 ml Luer Lock Syringe FDA UDI
- Model / Reference
- QIT011 FDA UDI
- Description
- 1 ml Luer Lock Syringe FDA UDI
Identifiers
- Primary DI / UDI-DI
- 23700550400732 FDA UDI
- 510(k) Number
- K203738 FDA UDI
- FDA Product Code
- FMF FDA UDI
- GMDN Term
- General-purpose syringe, single-use 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
Yes
FDA UDI
Over-the-Counter
No
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
MR Safe FDA UDI
Category: General-purpose syringe, single-use
Qitexio by Medex, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose syringe, single-use.
- Merit Medical® — Merit Medical Systems, Inc. · Class II
- SOFT-JECT® — Henke-Sass, Wolf GmbH · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- SURGYCO — Surgyco LLC · Class I
- NAMIC — MEDLINE INDUSTRIES, INC. · Class II
- HSW HENKE-JECT® — Henke-Sass, Wolf GmbH · Class II
- BD Safety-Lok — BECTON DICKINSON AND COMPANY · Class II
- SURGYCO — Surgyco LLC · Class I
Cleared under the same submission
K203738 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Medex, Inc.
Sources (2)
- FDA UDI 84af828a-109f-40ce-8ba6-8e05e0969e2f 35 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 2, 2026