FDA.reportPublic FDA data

TRIFURCATED EXTENSION SET

Primary DI
00810080610200
Brand
TRIFURCATED EXTENSION SET
Company
MPS Pharma & Medical, Inc.
Model
BTF-HM-3
Published
2022-08-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FPASet, Administration, Intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090809000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090809000MPS ACACIA POWER INJECTABLE INFUSION SETMps Acacia2009-04-28FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810080610207PackageGS150In Commercial Distribution
00810080610200PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081008061020710810080610207
00810080610200008100806102008100806102000810080610200

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous administration tubing extension setA collection of tubing and connectors intended to establish an extension of tubing where the standard length of the tubing in an intravenous (IV) administration set is insufficient. This is a single-use device.

Regulatory Flags#

DUNS number
117970217
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810080612525OptiDropper®, SafeFill™UA15-415-50-TRAY-15CR2026-05-14
00810080612532OptiDropper®, SafeFill™UA15-415-109-TRAY-5-WHT2026-05-14
00810080612549OptiDropper®UA15-415-10-BOT-52026-05-14
00810080612556OptiDropper®UA15-415-10-BOT-5-WHT2026-05-14
00810080612563SAFEFILL™UA15-415-50-TRAY-10-WHT2026-05-14
00810080612518CONNECTOR LUER FEMALE/MALEPLS616082025-11-07
00810080612501OptiDropper®, SafeFill™UA15-415-109-TRAY-52025-10-22
00810080612495OptiDropper®, SafeFill™UA15-415-50-TRAY-102025-08-19
10810080612492OptiDropper®, SafeFill™UA15-415-50-TRAY-102025-08-19
00810080612488OptiDropper®UA15-415-50-BOT-10BRW2025-08-15
10810080612485OptiDropper®UA15-415-50-BOT-10BRW2025-08-15
00810080612464OptiDropper®UA15-415-108-TRAY-72025-07-19
10810080612461OptiDropper®UA15-415-108-TRAY-72025-07-19
00810080612372OptiDropper™ AC211633-122025-05-13
10810080612379OptiDropper™ AC211633-122025-05-13
00810080612327OptiDropper™AC211631-22025-05-12
00810080612334OptiDropper™ AC211631-3002025-05-12
00810080612341OptiDropper™ AC211632-12025-05-12
00810080612358OptiDropper™AC211632-122025-05-12
00810080612365OptiDropper™AC211633-12025-05-12

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