Identity
- Trade Name
- NIM FLEX™ FDA UDI
- Generic Name
- Reinforced endotracheal tube, single-use FDA UDI
- Device Name
- ENDOTRACH TUBE 8229970 5PK EMG 7MM ROHS FDA UDI
- Model / Reference
- 8229970 FDA UDI
- Description
- ENDOTRACH TUBE 8229970 5PK EMG 7MM ROHS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20643169358809 FDA UDI
- 510(k) Number
- K925640 FDA UDI
- FDA Product Code
- ETN FDA UDI
- GMDN Term
- Reinforced endotracheal tube, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.1820 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Reinforced endotracheal tube, single-use
Nim Flex™ by Medtronic Xomed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Reinforced endotracheal tube, single-use.
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- Disposable Tracheal tubes — Shaoxing Carere Medical Appliance Co., Ltd. · Class IIa
- Disposable Tracheal Tubes With Cuff — NINGBO HUAKUN MEDICAL EQUIPMENT CO.,LTD · Class IIa
- cuff — Contec Medical Systems Co., Ltd. · Class I
- RUSCH — TELEFLEX INCORPORATED · Class II
- Welllead Reinforced Tracheal Tube — Well Lead Medical Co., Ltd · Class IIa
- Disposable Endotracheal Tubes — Rmist(Tianjin) Medical Device Co., Ltd. · Class IIa
- Endotracheal Tube — HANGZHOU FORMED MEDICAL DEVICES CO., LTD. · Class IIa
Cleared under the same submission
K925640 also covers:
- NIM — MEDTRONIC XOMED, INC.
- NIM — MEDTRONIC XOMED, INC.
- NIM — MEDTRONIC XOMED, INC.
- NIM FLEX™ — MEDTRONIC XOMED, INC.
- NIM FLEX™ — MEDTRONIC XOMED, INC.
- NIM FLEX™ — MEDTRONIC XOMED, INC.
- NIM FLEX™ — MEDTRONIC XOMED, INC.
- NIM FLEX™ — MEDTRONIC XOMED, INC.
- NIM FLEX™ — MEDTRONIC XOMED, INC.
- NIM FLEX™ — MEDTRONIC XOMED, INC.
- NIM® — MEDTRONIC XOMED, INC.
- NIM® — MEDTRONIC XOMED, 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
- Medtronic Xomed, Inc.
Sources (1)
- FDA UDI c138e9b4-b7c0-4665-868f-d8edb87c1afa 35 fields · synced Jun 1, 2026