FDA.reportPublic FDA data

Covidien NPB 492A, 590 and 592A Style Foam Cabinet Filters

Primary DI
00848530050610
Brand
Covidien NPB 492A, 590 and 592A Style Foam Cabinet Filters
Company
SUNSET HEALTHCARE SOLUTIONS, INC.
Model
OF6001-2
Catalog number
OF6001-2
Device description
Covidien NPB 492A, 590 and 592A Style Foam Cabinet Filters (2/pack).
Published
2018-07-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848530050610PrimaryGS10
10848530050617Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848530050610008485300506108485300506100848530050610
1084853005061710848530050617

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
PhoneEmail
877-578-6738customerservice@sunsethcs.com

Regulatory Flags#

DUNS number
141668116
Device count
2
Premarket exempt
true
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
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00848530109080CPAP HeadgearHG2062026-06-04
00848530109103CPAP HeadgearHG2072026-06-04
00848530108328Repair PartsRP0932026-06-03
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00848530109264CPAP MaskCM060M2026-06-03
00848530109271CPAP MaskCM060L2026-06-03
00848530109288CPAP MaskCM060XL2026-06-03
00848530108953Repair PartsRP1082026-06-02
00848530108960Repair PartsRP1092026-06-02
00848530108977Repair PartsRP1102026-06-02
00848530109011Repair PartsRP1112026-06-02
00848530109028Repair PartsRP1122026-06-02