FDA.reportPublic FDA data

LifeBubble

Primary DI
10850002447160
Brand
LifeBubble
Company
NOVONATE INC
Model
APL
Catalog number
APL
Device description
Adhesive Pack, Large (20/case)
Published
2022-02-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
KMKDevice, Intravascular Catheter Securement

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMKDevice, Intravascular Catheter SecurementGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850002447934PreviousGS10
10850002447160PrimaryGS10
00850002447163Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850002447934008500024479348500024479340850002447934
1085000244716010850002447160
00850002447163008500024471638500024471630850002447163

GMDN Terms#

Term, Definition table
TermDefinition
Wearable percutaneous catheter/tube holder, single-useA noninvasive device designed to fix a percutaneous (excluding intracranial) catheter, tube, and/or drain (e.g., IV, epidural, or drainage catheter, GI tube) to a patient's body; it may additionally be intended for holding a non-surgically-invasive tube (e.g., nasogastric tube) to the patient (universal holder). It is designed as an adhesive pad, a base plate, strip, or bandage that will attach to the patient's skin, and may include holes to allow suture fixation. The exposed side may have integrated fixation mechanism to hold the catheter/tube in place and may include a transparent film portion intended for fixation site monitoring. This is a single-use device.

Regulatory Flags#

DUNS number
080564237
Device count
20
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850002447085LifeBubbleLBLLBL2022-02-04
10850002447184LifeBubbleLKLLKL2022-02-04
10850002447207LifeBubbleLBSLBS2022-02-04
10850002447221LifeBubbleAPSAPS2022-02-04
10850002447245LifeBubbleLKSLKS2022-02-04
10850002447269LifeBubbleBBBB2022-02-04
00850002447095LifeBubbleLK20-SLK20-S2021-10-11
00850002447101LifeBubbleLB20-SLB20-S2021-10-11
00850002447118LifeBubbleAP20-SAP20-S2021-10-11
00850002447972LifeBubbleBB40BB402020-06-08
00850002447316LifeBubbleLEKLEK2025-07-18
00850002447910LifeBubbleLB20LB202019-09-12
00850002447927LifeBubbleLK20LK202019-09-12
00850002447934LifeBubbleAP20AP202019-09-12
00850002447088LifeBubbleLBLLBL2022-02-04
00850002447163LifeBubbleAPLAPL2022-02-04
00850002447187LifeBubbleLKLLKL2022-02-04
00850002447200LifeBubbleLBSLBS2022-02-04
00850002447224LifeBubbleAPSAPS2022-02-04
00850002447248LifeBubbleLKSLKS2022-02-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10618125192585Grip-LokTIDI PRODUCTS, LLCKMK2026-04-15
10816000014070ARROWTELEFLEX INCORPORATEDKMK2025-09-16
10801741082983StatLockBard Access Systems, Inc.KMK2025-05-02
10801741087582StatLockBard Access Systems, Inc.KMK2025-05-02
10816000013868ARROWTELEFLEX INCORPORATEDKMK2025-04-04
10618125192141Grip-LokTIDI PRODUCTS, LLCKMK2024-12-02
10885632416309HalyardOWENS & MINOR DISTRIBUTION, INC.KMK2024-07-30
10885632416279HalyardOWENS & MINOR DISTRIBUTION, INC.KMK2024-07-22
10885632416286HalyardOWENS & MINOR DISTRIBUTION, INC.KMK2024-07-22
10885632416293HalyardOWENS & MINOR DISTRIBUTION, INC.KMK2024-07-22
10618125135148Grip-LokTIDI PRODUCTS, LLCKMK2024-04-22
20653160370694CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2024-03-08
20653160370700CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2024-03-08
20653160370717CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2024-03-08
20653160370724CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2024-03-08
20653160370731CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2024-03-08
20653160370748CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2024-03-08
20653160370755CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2024-03-08
20653160371073CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2024-02-02
20653160369322MEDLINEMEDLINE INDUSTRIES, INC.KMK2023-12-01
30382905154035BD PhaSealBECTON DICKINSON PEN LIMITEDKMK2023-09-15
10686004000023UltraDressingI.V. House, Inc.KMK2023-07-21
10686004000030UtraDressingI.V. House, Inc.KMK2023-07-21
10686004000054UltraDressingI.V. House, Inc.KMK2023-07-21
10686004000320UltraDomeI.V. House, Inc.KMK2023-07-21
20686004000013UltraDomeI.V. House, Inc.KMK2023-07-21
20686004000303UltraDomeI.V. House, Inc.KMK2023-07-21
20686004000310UltraDomeI.V. House, Inc.KMK2023-07-21
30686004000041UltraDressingI.V. House, Inc.KMK2023-07-21
20653160358692CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2023-02-06