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SunMed LLC

FDA UDI

Class I (US FDA UDI)

by SunMed

Identity

Trade Name
SunMed LLC FDA UDI
Generic Name
Oxygen administration tubing FDA UDI
Device Name
Pediatric, Noon-intubated, 7ft Oral/Nasal with Oxygen Tubing FDA UDI
Model / Reference
5807F-SE FDA UDI
Description
Pediatric, Noon-intubated, 7ft Oral/Nasal with Oxygen Tubing FDA UDI

Identifiers

Catalog Number
5807F-SE FDA UDI
Primary DI / UDI-DI
10889483553619 FDA UDI
FDA Product Code
BYX FDA UDI
GMDN Term
Oxygen administration tubing FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
868.5860 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Length — 7 Feet FDA UDI

Category: Oxygen administration tubing

SunMed LLC by SunMed — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Oxygen administration tubing.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
SunMed

Sources (1)

  • FDA UDI 23a15f31-fac2-4ac3-90e4-28c51bbdbe88 35 fields · synced Jun 1, 2026