Care Touch

Primary DI
10370393311012
Brand
Care Touch
Company
FUTURE DIAGNOSTICS LLC
Model
IS311
Device description
Care Touch U-100 Insulin Syringes 31g 5/16"-8mm 1cc
Published
2017-03-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152808000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152808000U&U Insulin Syringe with/without Safety Retractable DeviceU&U Medical Technology Co, Ltd.2016-03-25MEG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10370393311012PackageGS15In Commercial Distribution
00370393311015PrimaryGS10
00370393000810Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1037039331101210370393311012
00370393311015003703933110153703933110150370393311015
00370393000810003703930008103703930008100370393000810

GMDN Terms#

Term, Definition table
TermDefinition
Hypodermic needle, single-useA non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume0.3Milliliter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
646-773-5813lenny@adelphiasupply.com

Regulatory Flags#

DUNS number
080113296
Device count
100
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00370393210202Care TouchCT2102018-02-05
00370393211056Care TouchCT-502018-02-05
00370393001084Care TouchCTk-502018-02-05
00370393215207Care TouchCTk-2152018-02-05
00370393216105Care TouchCTk-102018-02-16
00370393102019Care TouchPN-3131652016-08-31
00370393104013Care TouchPN-311462016-08-31
00370393116016Care TouchPN-3231652016-08-31
00370393130012Care TouchHN1812016-12-30
00370393131019Care TouchHN181122016-12-30
00370393140011Care TouchHN2212016-12-30
00370393302013Care TouchIS3012017-03-07
00370393310018Care TouchIS3152017-03-07
00370393311015Care TouchIS3112017-03-07
00370393540507Care TouchCTS60502016-08-31
00370393000049Care TouchPN-3131652016-08-31
00370393103016Care TouchPN-3151682016-08-31
20370393104017Care TouchPN-311462016-08-31
00370393115019Care TouchPN-3253242016-08-31
20370393116010Care TouchPN-3231652016-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09347144013062Metier MedicalMETIER MEDICAL LTDFMF2026-10-19
09347144013123Metier MedicalMETIER MEDICAL LTDFMF2026-10-19
09347144015004Metier MedicalMETIER MEDICAL LTDFMF2026-10-12
09347144016186Metier MedicalMETIER MEDICAL LTDFMF2026-10-12
09347144016216Metier MedicalMETIER MEDICAL LTDFMF2026-10-12
20612479288496McKessonMCKESSON MEDICAL-SURGICAL INC.FMF2026-10-08
20612479288526McKessonMCKESSON MEDICAL-SURGICAL INC.FMF2026-10-08
10304040193843Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040193850Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040193867Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040193874Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040193881Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040193898Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194109Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194116Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194208Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194215Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194222Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194239Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194246Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194253Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194260Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194277Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194284Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194291Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194307Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194314Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
05391530753982polycarbonate syringesDMC MEDICAL LIMITEDFMF2026-10-01
05391530753999polycarbonate syringesDMC MEDICAL LIMITEDFMF2026-10-01
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