Hudson Rci

FDA UDI

Class II (US FDA UDI)

by Teleflex Incorporated

Identity

Trade Name: HUDSON RCI FDA UDI
Generic Name: Inhalation therapy saline solution, isotonic FDA UDI
Device Name: AQUAPAK 0.45 NaCl, 760 mL FDA UDI
Model / Reference: IPN049254 FDA UDI
Description: AQUAPAK 0.45 NaCl, 760 mL FDA UDI

Identifiers

Catalog Number: 037-05 FDA UDI
Primary DI / UDI-DI: 14026704627810 FDA UDI
510(k) Number: K141214 FDA UDI
FDA Product Code: CAF FDA UDI
GMDN Term: Inhalation therapy saline solution, isotonic FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5630 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Inhalation therapy saline solution, isotonic

Hudson Rci by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Inhalation therapy saline solution, isotonic.

Sodium Chloride Inhalation Solution, USP, 0.9%-3mL — LIFESTAR PHARMA LLC · Class II
Sodium Chloride Inhalation Solution, USP 0.9% — Nephron Pharmaceuticals Corp. · Class II
HUDSON RCI — MEDLINE INDUSTRIES, INC. · Class II
HUDSON RCI — MEDLINE INDUSTRIES, INC. · Class II
HUDSON RCI — MEDLINE INDUSTRIES, INC. · Class II
HUDSON RCI — MEDLINE INDUSTRIES, INC. · Class II
Sodium Chloride Inhalation Solution, USP, 0.9% 3 mL UDV individually wrapped — RITEDOSE PHARMACEUTICALS, LLC · Class II
Sodium Chloride Inhalation Solution, USP, 0.9%-5mL — LIFESTAR PHARMA LLC · Class II

Cleared under the same submission

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: Teleflex Incorporated

Sources (1)

FDA UDI 6a08d4d8-d0a1-49f1-ab69-5b588efe82f9 36 fields · synced May 30, 2026