FDA.report

N/A

Primary DI
00607411951114
Brand
N/A
Company
SALTER LABS
Model
1700-4
Catalog number
1700-4
Device description
Aloft Salter lightweight, Nasal O2 Cannula (Adult), 4' (1.2 m) 0 to 6 LPM, Non DEHP.
Published
2016-12-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
CATCANNULA, NASAL, OXYGEN

Product Code Classifications

CodeDeviceSpecialtyClass
CATCannula, Nasal, OxygenAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10607411951111PackageGS150In Commercial Distribution
00607411951114PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1060741195111110607411951111
00607411951114006074119511146074119511140607411951114

GMDN Terms

TermDefinition
Basic nasal oxygen cannulaA non-sterile, semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with a headstrap, to administer oxygen (O2). It is commonly known as "nasal prongs". This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature-40 Degrees Celsius60 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)421-0024customercare@salterlabs.com

Regulatory Flags

DUNS number
022721133
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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