FDA.reportPublic FDA data

TERUMO SAMPLING SITE COUPLER

Primary DI
54987350731277
Brand
TERUMO SAMPLING SITE COUPLER
Company
TERUMO CORPORATION
Model
TC*MP1
Device description
TERUMO SAMPLING SITE COUPLER
Published
2016-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KSSSupplies, Blood-Bank

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KSSSupplies, Blood-BankHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
54987350731277PackageGS120In Commercial Distribution
34987350731273PrimaryGS10
04987350731272Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5498735073127754987350731277
3498735073127334987350731273
04987350731272049873507312724987350731272

GMDN Terms#

Term, Definition table
TermDefinition
Fluid transfer set, general-purposeA collection of sterile devices and supplies designed to transfer several types of medical fluids (e.g., drugs, vaccines, blood, and solutions) between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Fragile
Special Storage Condition, Specify00Keep away from rain
Special Storage Condition, Specify00Keep away from sunlight

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
13032052510FDAUDIprogram@terumobct.com

Regulatory Flags#

DUNS number
690543319
Device count
50
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
04987350740601GLIDEWIRE GT-RGT*GW1618AGT*GW1618A2026-02-06
04987350740625GLIDEWIRE GT-RGT*GA1818AGT*GA1818A2026-02-06
04987350740649GLIDEWIRE GT-RGT*GA1822AGT*GA1822A2026-02-06
54987350740668GLIDEWIRE GT-RGT*GE1818AGT*GE1818A2026-02-06
04987350740687GLIDEWIRE GT-RGT*GE1822AGT*GE1822A2026-02-06
54987350740699GLIDEWIRE GT-RGT*GW1818AGT*GW1818A2026-02-06
04987350740700GLIDEWIRE GT-RGT*GW1822AGT*GW1822A2026-02-06
04987350745422GLIDEWIRE GT-RGT*GW1622AGT*GW1622A2026-02-06
04987350744487DUALVIEWTU-DSS01CTU*DV01U2026-01-21
54953170465050VISIGLIDEG-240-2527AN36222312025-07-14
54953170465067VISIGLIDEG-240-2545AN36224312025-07-14
54953170465074VISIGLIDEG-240-3527AN36226312025-07-14
54953170465081VISIGLIDEG-240-3545AN36228312025-07-14
54953170465098VISIGLIDEG-240-2527SN36221312025-07-14
54953170465104VISIGLIDEG-240-2545SN36223312025-07-14
54953170465111VISIGLIDEG-240-3527SN36225312025-07-14
54953170465128VISIGLIDEG-240-3545SN36227312025-07-14
54953170465135VISIGLIDE2G-260-2527AN53677312025-07-14
54953170465142VISIGLIDE2G-260-2545AN53681312025-07-14
54953170465159VISIGLIDE2G-260-3527AN53679312025-07-14

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Primary DI, Brand, Company table
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20812269031275TypesafeTYPENEX MEDICAL LLCKSS2022-11-21
00812269031295TypesafeTYPENEX MEDICAL LLCKSS2022-11-21
20810020440533Hematype Segment DeviceFresenius Kabi AGKSS2022-11-08
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24086000903268Fenwal Slide ClampFresenius Kabi AGKSS2022-11-04
00810106410142Rad-Sure™ASHLAND SPECIALTY INGREDIENTS G.P.KSS2022-09-23
00810106410159Rad-Sure™ASHLAND SPECIALTY INGREDIENTS G.P.KSS2022-09-23
00810106410289Rad-Sure™ASHLAND SPECIALTY INGREDIENTS G.P.KSS2022-09-23
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