BEUDAMED

FDA UDI Not in Commercial Distribution 🇺🇸 United States

n/a

DI: 00607411200007 · Model: SO-1943 · SALTER LABS

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Product Codes

1

GMDN Terms

1

Identifiers

2

Pkg Device Count

1

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Basic Information

Brand Name: n/a
Primary DI: 00607411200007
Version / Model: SO-1943
Catalog Number: 2001-1
Company Name: SALTER LABS
Labeler DUNS: 022721133
Distribution Status: Not in Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2016-11-30
Public Version: 5
Public Version Date: 2025-12-09
Public Version Status: Update
Public Device Record Key: 813a76f8-ca4a-4ec4-8dee-90aaeb93365d
Distribution End Date: 2025-11-27

Device Description

Oxygen Tubing with 2 standard connectors, 1’ (.3 m)

Device Characteristics

Single Use: No
Prescription Use (Rx): Yes
Over the Counter (OTC): No
Kit: Yes
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: Yes
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: No
PM Exempt: Yes
Has Serial Number: No
Has Lot/Batch Number: Yes
Has Manufacturing Date: No
Has Expiration Date: No
Has Donation ID: No

Sterilization

Is Sterile: No
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BYX	TUBING, PRESSURE AND ACCESSORIES	Anesthesiology	868.5860	1

GMDN Terms

Code	Name	Definition	Implantable	Status
12875	Oxygen administration tubing	A length of flexible noninvasive tube, typically a small bore, thick-walled, anti-kink tubing (to prevent blockage) intended for the delivery of a pure oxygen (O2), or an O2 enriched gas, to a mask or nasal cannula (not included), during delivery of dry O2 to the patient. The tubing is typically available in standard coil lengths and is cut by clinical staff to appropriate lengths to create an extension or connecting piece. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00607411200007	GS1
Package	01060741120008	GS1		50	Not in Commercial Distribution	2025-11-27

Customer Contacts

Phone: +1(800)421-0024
Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Adult

Storage Conditions

Type: Special Storage Condition, Specify
Special Conditions: N/A
Type: Handling Environment Temperature
Temperature Range: 5 – 40 Degrees Celsius
Type: Storage Environment Temperature
Temperature Range: -40 – 60 Degrees Celsius