FDA.report

Mark Kit

Primary DI
00848530051235
Brand
Mark Kit
Company
SUNSET HEALTHCARE SOLUTIONS, INC.
Model
OF11004SP
Catalog number
OF11004SP
Device description
This kit contains: 2 OF11004 Foam Cabinet Filters, 1 BF1438 Final Bacteria Filter.
Published
2018-07-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
CAHFilter, Bacterial, Breathing-Circuit

Product Code Classifications

CodeDeviceSpecialtyClass
CAHFilter, Bacterial, Breathing-CircuitAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00848530051235PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00848530051235008485300512358485300512350848530051235

GMDN Terms

TermDefinition
Anaesthesia conduction filterA sterile microporous membrane used to minimize particulate (foreign material) contamination of a local anaesthetic during administration to a patient (e.g., through an anaesthesia conduction catheter). This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
877-578-6738customerservice@sunsethcs.com

Regulatory Flags

DUNS number
141668116
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
false
Sterilization required before use
false

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10848530108356Vented CPAP Masks VC10092026-03-03
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10848530108387Vented CPAP Masks VC10122026-03-03
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