FDA.report

n/a

Primary DI
10607411001243
Brand
n/a
Company
SALTER LABS
Model
7000-0
Catalog number
7000-0
Device description
Water Trap
Published
2016-11-30
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
BYXTUBING, PRESSURE AND ACCESSORIES

Product Code Classifications

CodeDeviceSpecialtyClass
BYXTubing, Pressure And AccessoriesAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10607411001243PackageGS110In Commercial Distribution
20607411001240PackageGS125In Commercial Distribution
00607411001246PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1060741100124310607411001243
2060741100124020607411001240
00607411001246006074110012466074110012460607411001246

GMDN Terms

TermDefinition
Breathing circuit condensate trap, single-useA non-sterile device intended to be integrated within a breathing circuit (e.g., ventilator or respirator breathing circuit) to collect the condensate which accumulates typically during heated humidification. It includes a fluid collection container with input and output connections, and may have an automatic seal to prevent fluid leaks when removed from the circuit; it does not include a moisture filter. This is a single-use device.

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
true
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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