FDA.reportPublic FDA data

Terumo

Primary DI
35413206251224
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
OTC
false
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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
370193559
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
true
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
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
05413206251223TerumoNF-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
05413206251223TerumoTerumo Europe NVQYM2023-10-27