FDA.reportPublic FDA data

NA

Primary DI
04046964318276
Brand
NA
Company
B. BRAUN MEDICAL INC.
Model
622470
Catalog number
622470
Device description
SPECTRALINE SYRINGE LABELS
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
LYVLABEL OR TAG, STERILE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYVLabel Or Tag, SterileGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046964318276PrimaryGS10
04046964318252Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046964318276040469643182764046964318276
04046964318252040469643182524046964318252

GMDN Terms#

Term, Definition table
TermDefinition
Procedural medication labelling setA collection of devices intended to provide clinical staff with a standardized method to label medications, medication containers (e.g., syringes, medicine cups, basins), or other solutions in and outside of the sterile field in perioperative and other procedural settings. It typically includes a permanent marking pen and various labels typically made of moisture resistant plastic material and provided with standard medication/drug/solution text (e.g., lidocaine, heparin, morphine sulfate, saline, sterile water) which can be further qualified using the pen; the labels may also include additional text fields (e.g., for date, initials). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)227-2862BBMUS_Service.EmailOrders@bbraun.com

Regulatory Flags#

DUNS number
002397347
Device count
25
DM exempt
false
Premarket exempt
true
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
04046955672370Design Options®5606805606802026-05-24
04046955850839Omnifix®4616025V-024616025V-022026-03-08
04046955897186Design Options®5703495703492026-03-02
04045928020866Design Options®5521505521502026-02-03
04046955900534Perifix®5520475520472026-02-03
04046955900855Design Options®5555255555252026-02-03
04046955901197Combined Spinal & Epidural5301535301532026-02-03
04045928020200Design Options®5301855301852020-04-24
04046955966165Design Options®5703605703602026-01-25
04046955086832Extension Set4904964904962017-10-28
04046964296710Extension Set4565214565212016-09-23
04046964525728Extension Set4903164903162016-09-23
04046964296697Extension Set4565204565202016-09-23
04046964183218Perifix®4150004150002016-09-23
04046964941054PERIFIX™3391603391602016-10-24
04046964332333VENA TECH6107716107712017-01-18
04046955672028Design Options®5606765606762025-12-22
04046955745753Introcan Safety ® 24242001-024242001-022025-12-19
04046955745838Introcan Safety ® 24242003-024242003-022025-12-19
04046955745913Introcan Safety ® 24242005-024242005-022025-12-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B050SL1000021Sterile LabelsTYPENEX MEDICAL LLCLYV2026-03-17
17540277009646PharmaTagsRMAC Surgical, IncLYV2026-03-12
17540277009639PharmaTagsRMAC Surgical, IncLYV2026-03-03
17540277000001PharmaTagsRMAC Surgical, IncLYV2026-02-06
10754027700104PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700111PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700142PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700173PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700265PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700715PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700722PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700739PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700746PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700753PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700777PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700784PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700791PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700807PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700814PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700821PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700838PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700845PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700852PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700869PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700876PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700883PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700890PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700906PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700913PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700920PharmaTagsRMAC Surgical, IncLYV2026-02-02