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Medline

FDA UDI

Class II (US FDA UDI)

by Medline Industries, Inc.

Identity

Trade Name
Medline FDA UDI
Generic Name
Gas-sampling/monitoring respiratory tubing, single-use, sterile FDA UDI
Device Name
GAS SAMPLING LINE,10' MF,.05 ID FDA UDI
Model / Reference
DYNJAA21 FDA UDI
Description
GAS SAMPLING LINE,10' MF,.05 ID FDA UDI

Identifiers

Catalog Number
DYNJAA21 FDA UDI
Primary DI / UDI-DI
10080196551361 FDA UDI
510(k) Number
K946044 FDA UDI
FDA Product Code
CCK FDA UDI
GMDN Term
Gas-sampling/monitoring respiratory tubing, single-use, sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.1400 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

Category: Gas-sampling/monitoring respiratory tubing, single-use, sterile

Medline by Medline Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Gas-sampling/monitoring respiratory tubing, single-use, sterile.

Cleared under the same submission

K946044 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medline Industries, Inc.

Sources (1)

  • FDA UDI 76c74a64-ef26-4c93-91b8-f666c66c5d79 37 fields · synced Jun 8, 2026