FDA.reportPublic FDA data

Pioneer Kit

Primary DI
00848530051204
Brand
Pioneer Kit
Company
SUNSET HEALTHCARE SOLUTIONS, INC.
Model
OF11002SP
Catalog number
OF11002SP
Device description
This kit contains: 2 OF11002 Foam Cabinet Filters, 1 BF316 Final Bacteria Filter, 1 BFH6S 6in HEPA Capsule
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
00848530051204PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848530051204008485300512048485300512040848530051204

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
1
Premarket exempt
true
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848530107451Stratus Power SwitchRP0762025-09-24
00848530107468Stratus Pneumatic ValveRP0772025-09-24
00848530108984CPAP MaskCM206SNH2026-06-04
00848530108991CPAP MaskCM206MNH2026-06-04
00848530109004CPAP MaskCM206LNH2026-06-04
00848530109042CPAP MaskCM207SNH2026-06-04
00848530109059CPAP MaskCM207MNH2026-06-04
00848530109066CPAP MaskCM207LNH2026-06-04
00848530109080CPAP HeadgearHG2062026-06-04
00848530109103CPAP HeadgearHG2072026-06-04
00848530108328Repair PartsRP0932026-06-03
00848530109097CPAP MaskCM060S2026-06-03
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