FDA.report

Tamper Evident Clamp

Primary DI
04046964199998
Brand
Tamper Evident Clamp
Company
B. BRAUN MEDICAL INC.
Model
2112432
Catalog number
2112432
Device description
PINNACLE® TPN Bag Tamper Resistant Clamps, smaller than 1 L
Published
2016-09-23
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

Related Records

Contact Domains

Product Codes

CodeName
KPECONTAINER, I.V.

Product Code Classifications

CodeDeviceSpecialtyClass
KPEContainer, I.V.General Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04046964199998PackageGS110In Commercial Distribution
04046964199981PrimaryGS10
04046964245534Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046964199998040469641999984046964199998
04046964199981040469641999814046964199981
04046964245534040469642455344046964245534

GMDN Terms

TermDefinition
Medical tubing clip/clamp, temporary, non-calibrated, single-useA manual device designed to compress a piece of medical device tubing or tubular container to reversibly occlude its lumen and stop the flow of material within; it is not intended for patient-contact. It has a manual mechanism (e.g., hinging, roller-type, vice-like) whereby pressure on the tube can be applied or removed, however it is not a calibrated device (e.g., it is often a roller type, clip, or screw-clamp). It may be referred to as a clip or a clamp. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)227-2862BBMUS_Service.EmailOrders@bbraun.com

Regulatory Flags

DUNS number
002397347
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
true
Sterilization required before use
false

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