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Timeter

FDA UDI

Class II (US FDA UDI)

by Allied Medical LLC

Identity

Trade Name
Timeter FDA UDI
Generic Name
Oxygen administration tent, neonatal/paediatric FDA UDI
Device Name
CAM 4, w/ PCS 414, 230 V / 50 Hz FDA UDI
Model / Reference
16394 FDA UDI
Description
CAM 4, w/ PCS 414, 230 V / 50 Hz FDA UDI

Identifiers

Catalog Number
T16394 FDA UDI
Primary DI / UDI-DI
00026072001646 FDA UDI
510(k) Number
K941547 FDA UDI
FDA Product Code
BYK FDA UDI
GMDN Term
Oxygen administration tent, neonatal/paediatric FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5710 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

Yes

FDA UDI

Category: Oxygen administration tent, neonatal/paediatric

Timeter by Allied Medical LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Oxygen administration tent, neonatal/paediatric.

Cleared under the same submission

K941547 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Allied Medical LLC

Sources (1)

  • FDA UDI 4df8b1d9-794e-4b98-9cdc-2b56d3e5d8eb 35 fields · synced May 31, 2026