FDA.reportPublic FDA data

K-Pack II

Primary DI
55413206051040
Brand
K-Pack II
Company
Terumo Europe NV
Model
KN-3013RBKT
Catalog number
KN-3013RBKT
Device description
K-Pack II Needle
Published
2016-09-05
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
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110850000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110850000K-PACK II NEEDLE- 27G & 30G THIN WALLTerumo Europe N.V.2011-06-09FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
55413206051040PackageGS15000In Commercial Distribution
05413206051045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5541320605104055413206051040
05413206051045054132060510455413206051045

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
Needle Gauge30Gauge

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not store at extreme temperature and humidity.
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
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
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
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

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