FDA.reportPublic FDA data

Terumo

Primary DI
05413206251223
Brand
Terumo
Company
Terumo Europe NV
Model
NF-3013RBKE05M
Catalog number
NF-3013RBKE05M
Device description
Injection Filter Needle
Published
2023-10-27
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
QYMOphthalmic Needle

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QYMOphthalmic NeedleGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230951000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230951000Terumo Injection Filter Needle (NF-3013RBKE05M)Terumo Europe N.V.2023-10-18QYM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
35413206251224PackageGS1100In Commercial Distribution
55413206251228PackageGS130In Commercial Distribution
05413206251223PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3541320625122435413206251224
5541320625122855413206251228
05413206251223054132062512235413206251223

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
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge30Gauge

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight. Keep dry.
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(800)283-7866tmccustomer.admin@terumomedical.com

Regulatory Flags#

DUNS number
370193559
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05413206050260K-Pack Surshield™KN-S2516RBKN-S2516RB2016-09-05
05413206223640K-Pack IIKN-2713RKT50KN-2713RKT502018-05-07
05413206223688K-Pack IIKN-3013RKT50KN-3013RKT502018-05-07
05413206211418K-Pack IIKN-2719RBTSKN-2719RBTS2016-09-05
05413206346042TerumoKH-2713RBBTCKH-2713RBBTC2025-09-16
05413206346059TerumoKH-2913RBBTCKH-2913RBBTC2025-09-16
05413206346219K-Pack Surshield™KN-S2713RBTKN-S2713RBT2025-09-16
05413206346110K-Pack Embrace™KNAS-2516RBKNAS-2516RB2025-09-15
05413206346127K-Pack Embrace™KNAS-2525RBKNAS-2525RB2025-09-15
55413206346115K-Pack Embrace™KNAS-2516RBKNAS-2516RB2025-09-15
55413206346122K-Pack Embrace™KNAS-2525RBKNAS-2525RB2025-09-15
35413206251224TerumoNF-3013RBKE05MNF-3013RBKE05M2023-10-27
05413206050277K-Pack Surshield™KN-S2713RBKN-S2713RB2016-09-05
05413206222452Surguard™3SG3-1938RBSG3-1938RB2022-10-28
05413206222469Surguard™3SG3-2138RBSG3-2138RB2022-10-28
05413206222476Surguard™3SG3-2516RBSG3-2516RB2022-10-28
05413206054923SURFLO™SV-S23FL35SV-S23FL352016-09-05
05413206054947SURFLO™SV-S25FL35SV-S25FL352016-09-05
05413206214914SURFLO™SV-S25FL35CSV-S25FL35C2017-06-21
05413206222445Surguard™3SG3-1925RBSG3-1925RB2022-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04573545740015STERiJECT OPHTHALMIC NEEDLE™ Low Dead Space (LDS)TSK LABORATORY INTERNATIONAL JAPAN K.K.QYM2025-07-14
04573545740022STERiJECT OPHTHALMIC NEEDLE™ Low Dead Space (LDS)TSK LABORATORY INTERNATIONAL JAPAN K.K.QYM2025-07-14
04573545740039STERiJECT OPHTHALMIC NEEDLE™ Low Dead Space (LDS)TSK LABORATORY INTERNATIONAL JAPAN K.K.QYM2025-07-14
04573545740046STERiJECT OPHTHALMIC NEEDLE™ Low Dead Space (LDS)TSK LABORATORY INTERNATIONAL JAPAN K.K.QYM2025-07-14
04573545740053STERiJECT OPHTHALMIC NEEDLE™ Low Dead Space (LDS)TSK LABORATORY INTERNATIONAL JAPAN K.K.QYM2025-07-14
04573545740060STERiJECT OPHTHALMIC NEEDLE™ Low Dead Space (LDS)TSK LABORATORY INTERNATIONAL JAPAN K.K.QYM2025-07-14
04573545740077STERiJECT OPHTHALMIC NEEDLE™ TSK LABORATORY INTERNATIONAL JAPAN K.K.QYM2025-07-14
04573545740107STERiJECT OPHTHALMIC NEEDLE™ TSK LABORATORY INTERNATIONAL JAPAN K.K.QYM2025-07-14
04571603050014STERiJECT OPHTHALMIC NEEDLE™ Low Dead Space (LDS)TSK LABORATORY INTERNATIONAL JAPAN K.K.QYM2025-07-14
04571603050021STERiJECT OPHTHALMIC NEEDLE™ Low Dead Space (LDS)TSK LABORATORY INTERNATIONAL JAPAN K.K.QYM2025-07-14
04571603050038STERiJECT OPHTHALMIC NEEDLE™ Low Dead Space (LDS)TSK LABORATORY INTERNATIONAL JAPAN K.K.QYM2025-07-14
04571603050045STERiJECT OPHTHALMIC NEEDLE™ Low Dead Space (LDS)TSK LABORATORY INTERNATIONAL JAPAN K.K.QYM2025-07-14
04571603050052STERiJECT OPHTHALMIC NEEDLE™ Low Dead Space (LDS)TSK LABORATORY INTERNATIONAL JAPAN K.K.QYM2025-07-14
04571603050069STERiJECT OPHTHALMIC NEEDLE™ Low Dead Space (LDS)TSK LABORATORY INTERNATIONAL JAPAN K.K.QYM2025-07-14
04571603050076STERiJECT OPHTHALMIC NEEDLE™ TSK LABORATORY INTERNATIONAL JAPAN K.K.QYM2025-07-14
04571603050083STERiJECT OPHTHALMIC NEEDLE™ TSK LABORATORY INTERNATIONAL JAPAN K.K.QYM2025-07-14
00850040387360VitreJect-DL Ophthalmic NeedleOcuject, LLCQYM2025-02-28
00855265008861VitreJect Ophthalmic NeedleOcuject, LLCQYM2025-02-28
00855265008885VitreJect Ophthalmic NeedleOcuject, LLCQYM2025-02-28
00855265008915VitreJect Ophthalmic NeedleOcuject, LLCQYM2025-02-28
00850040387377VitreJect-DL Ophthalmic NeedleOcuject, LLCQYM2025-02-28
00855265008038VitreJect Ophthalmic NeedleOcuject, LLCQYM2025-02-28
10855265008868VitreJect Ophthalmic NeedleOcuject, LLCQYM2025-02-28
00855265008892VitreJect Ophthalmic NeedleOcuject, LLCQYM2025-02-28
00855265008922VitreJect Ophthalmic NeedleOcuject, LLCQYM2025-02-28
35413206251224TerumoTerumo Europe NVQYM2023-10-27