Set, Transfer & Flood, Blood

Primary DI
10816513024535
Brand
Set, Transfer & Flood, Blood
Company
MPS MEDICAL, INC
Model
BTF-HM-3
Published
2019-09-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
10816513024535PackageGS150In Commercial Distribution
00816513024538PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081651302453510816513024535
00816513024538008165130245388165130245380816513024538

GMDN Terms#

Term, Definition table
TermDefinition
Medication transfer setA collection of sterile devices and supplies designed to transfer parenteral medications, and sometimes intravenous (IV) fluids, between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]; it may also be used to reconstitute medication for its preparation and administration. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079636164
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816513022701Set, I.V. Fluid Transfer17789HP3M-10PK2019-03-12
00816513023418Set, I.V. Fluid TransferNP-0052019-03-12
00816513023456Set, I.V. Fluid TransferNP-0062019-03-12
00816513023463Single Lead High Volume Pump Chamber SetG82721-MF2019-03-12
00816513023562Single Lead High Volume Pump Chamber SetG827331-M2019-03-12
00816513023883Set, I.V. Fluid TransferKMI-LTP2019-03-12
00816513024101Set, I.V. Fluid TransferHR-0452019-03-12
00816513024545Dual Lead High Volume Pump Chamber SetG82762-M2019-09-06
00816513024552Triple Lead High Volume Pump Chamber SetG82763-M2019-09-06
00816513024569Single lead High Volume Pump Chamber Set w/WeightG82713-M2019-09-30
00816513024873Set, I.V. Fluid Transfer19DTP2020-02-07
00816513025016Set, I.V. Fluid TransferNP-0192020-02-28
00816513025023Set, I.V. Fluid TransferNP-0202020-02-28
00816513025030Set, I.V. Fluid TransferNP-0212020-04-08
00816513020011Set, I.V. Fluid Transfer1 PHARM-62016-05-23
00816513020028Set, I.V. Fluid Transfer1 PHARM-6FG2016-05-23
00816513020035Set, I.V. Fluid Transfer17787HP3M2016-05-23
00816513020042Set, I.V. Fluid Transfer17788HP3M2016-05-23
00816513020059Set, I.V. Fluid Transfer17789HP2016-05-26
00816513020066Set, I.V. Fluid Transfer17789HP3M2016-05-23

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04038917423410Safety-Multifly® 23G w.holderSarstedt Aktiengesellschaft & Co.KGFPA2024-02-20
08436020769177DOSI-FLOWLEVENTON SAUFPA2023-09-08
08436020769184DOSI-FLOWLEVENTON SAUFPA2023-09-08
07613117017422Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017446Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017460Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017484Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017507Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017521Soft-Release-MicroYpsomed AGFPA2020-09-15
08498840006535VYGONVygon CorporationFPA2020-03-12
04038917423892Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-12-13
04038917423724Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423755Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
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04038917423922Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
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04038917423960Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423977Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423991Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917424004Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
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